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KITE PHARMA, INC. logo

QA Specialist III

KITE PHARMA, INC.Santa Monica, CA

$107,185 - $138,710 / year

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description We are seeking a highly motivated individual contributor to join us as a QA Specialist III within External Quality embedded within Kite's External Quality Organization. The QA Specialist III will report to the Quality Director, External Quality. Scope of the External Quality group includes quality oversight of contracted service providers such as development and manufacturing organizations(CMO/CDMO), contract testing labs (CTLs) and quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space. The QA Specialist III will have opportunities to work and share knowledge with partners across Kite's Global Technical Operations (e.g. Quality Control, Analytical Development, Process Development, Quality, Manufacturing, Supply Chain, and Regulatory) as well as international partners. The ideal candidate will have strong technical skills (knowledge of one or more of the following: cell therapy, bioassays, viral vector, and testing operations), Quality and Compliance background (Biologics, Drug, regulation), and understanding of the drug development lifecycle. This position will be based at Kite's headquarters in Santa Monica, CA. Responsibilities of the QA Specialist III include: Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities. Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records, investigations, corrective actions, change controls, protocols and reports, annual product quality reviews, IND/BLA/MAA CMC modules, Quality Agreements. Compilation of critical material and product disposition packages. Project management of disposition deliverables (e.g. investigations, batch records) ensuring timely critical material and/or product supply. Perform disposition (release) of product from CMOs. Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kite's CMOs. Assist, gather and analyze information to support External Supply Quarterly Management Review, provide mitigation plans for issues and risks. Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations. Up to 10% travel (domestic) Basic Qualifications: Master's Degree and 3+ years' experience in GMP environment related field OR Bachelor's Degree and 5+ years' experience in GMP environment related field Preferred Qualifications: Working with or at contract manufacturing or testing organizations or supporting partnerships. Diplomacy skills and ability to assess performance and proactively identify and mitigate risks Experience with collaborating in a cross-functional working model with support from fully-and partially dedicated resources; ability to manage through influence. Experience with direct FDA interaction (or other regulatory agencies) Experience writing, evaluating and closing investigations, CAPAs and change control records. Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies Excellent oral and written communication skills Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. Previous experience in Quality Control, Quality Assurance or Analytical Science People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 2 weeks ago

Inotiv logo

QA Auditor

InotivGaithersburg, MD

$69,700 - $85,000 / year

Demonstrate Inotiv Core Values Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures Maintain confidential information General Interact with clients, other employees, and the community in a professional manner Support and participate in company initiatives as directed Maintain thorough knowledge of facility SOPs, policies, study protocols, etc. Adhere to all safety regulations and procedures Provide assistance or support to other Inotiv QA team members as necessary Perform other duties as assigned Specific Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulations Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations (audits may include direct observation of study conduct and/or laboratory processes, review of protocols, study data and reports, or review of facility records and SOPs as well as subcontractor contributions) Prepare an audit report and submit all findings to Study Director/Principal Investigator and management promptly Issue accurate quality assurance statements for inclusion in final reports Become familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QC Input and/or update information in the Master Schedule program as required by GLP regulations and SOPs Independently conduct process or facility inspections Assist with audits and inspections conducted by Sponsors and regulatory agencies, as requested Conduct quality training for new hires and other employees, as assigned. Participate in or lead subcontractor and/or vendor evaluations Serve as a resource to represent the QA team on regulatory topics (e.g, at study initiation meetings), as requested Participate in departmental business, process or general regulatory projects, as assigned Perform other duties as assigned. Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.Education and Experience B.S. in chemistry or life sciences or Bachelor's degree or higher in a related field and Two to four years of experience in a GLP or similarly regulated environment preferably with 1 or more years of auditing experience, or Equivalent combination of education and regulatory, quality, compliance and/or industry experience. Skills and Abilities Excellent written and verbal communication and interpersonal skills with ability to work with personnel at all levels of the organization Good organizational skills and detail oriented A working knowledge and awareness of general laboratory procedures Ability to comprehend and apply applicable government regulations Displays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routine Ability to work independently and follow written instructions Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint) Ability to comprehend and apply applicable government regulations Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions Experience with quality systems management and enterprise quality management software preferred Performance Requirements General Ability to read, write, speak and understand oral and written instructions Available for occasional business travel Physical Activity Requires moderate physical activity including: Standing and/or walking for four (4) or more hours per day Repetitive movement of hands and fingers Reaching and heavy lifting (up to 50lbs) Prolonged periods of sitting and computer work May require transit between buildings or sites as well as walking over rough terrain Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level. Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world. Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more! Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

Posted 1 week ago

Johnson & Johnson logo

QA Technician I

Johnson & JohnsonBridgewater, MA

$38,500 - $61,985 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Control Job Category: Business Enablement/Support All Job Posting Locations: Bridgewater, Massachusetts, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . This is a field-based role available in all cities within Massachusetts. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for QA Technician I. Purpose: Our quality control technicians are responsible for ensuring company products comply with internal and external specifications. They achieve this by performing a variety of routine and non-routine inspections and evaluations. During inspection the quality technician will perform routine product inspections and analyses, generally of finished goods, components, and raw materials. These tasks will include comparing inspection results to defined requirements or specifications and documents differences found. Technical drawing, material standard reading skills are required, which includes general awareness of GD&T principles. The technician will apply their digital literacy skills to access these specification materials and to record the inspection findings in the approved digital application. Where needed the technician will communicate with more experienced personnel to consult and confirm presence of non-conformances and subsequent product disposition. As part of our team they will also support broader quality efforts. This may include first article inspections, where they may execute moderately complex tests and analyses to assure product compliance with established specifications. These tests and analyses may require involved calculations and documentation that shows the results of tests performed. As part of their daily functions they will also be performing Batch Release and Records Management. This will require them to review batch records to ensure compliance with policies, procedures and regulations. They will ensure batch records are complete and accurate. They will be responsible to identify, record and report batch non-conformances and holds. For record management they will store and maintain batch files either physically or electronically based on established guidelines. You will be responsible for: Apply principles of Good Documentation Practices. Provide assistance in validation activities. Initiate non-conformances within the applicable software application. Provide metrics and updates on executions. Review and complete their training records on time. Perform document change management actions per local procedures. Use computer-based applications to review, complete and release (as applicable): Inventory, Batch records, company and team communications, Inspection equipment. Perform additional task on supervisor's request that are within experience and personnel capability EXPERIENCE AND EDUCATION Education: High School/Secondary Education or Equivalent. Technical skills: Digital Literacy, general awareness of GD&T principles, can read and understand material standards, can read and understand technical drawings (blueprints). Social skills: Quality focused, flexibility, teamwork, service oriented, strong english written and verbal communication, organized. Experience: Generally, requires (0-2) years related experience Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Agility Jumps, Compliance Management, Curious Mindset, Customer Centricity, Detail-Oriented, Document Management, Factory Acceptance Test (FAT), Persistence and Tenacity, Process Oriented, Professional Ethics, Quality Control (QC), Quality Standards, Quality Systems Documentation, Regulatory Compliance, Technical Support The anticipated base pay range for this position is : $38,500.00 - $61,985.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation- 120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Colorado- 48 hours per calendar year; for employees who reside in the State of Washington- 56 hours per calendar year Holiday pay, including Floating Holidays- 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave- 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave- 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave- 80 hours in a 52-week rolling period10 days Volunteer Leave- 32 hours per calendar year Military Spouse Time-Off- 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Posted 1 week ago

P logo

QA Specialist/Environmental Engineer

Perma-FixGainesville, FL
Description Non-Exempt - This position is responsible for evaluation of the effectiveness of systems and processes in meeting regulatory requirements and protecting the health and safety of the public and PFF employees and reporting on the findings and coordinating and/or assisting in the development of any necessary corrective actions. The EHSQ manager has authorized the QA Specialist to access all work areas and records and the organizational freedom to function effectively without hindrance or reservation, to identify quality problems, stop unsatisfactory work and control further processing of work; initiate, recommend and approve solutions; verify implementation of solutions; and assure that measures of control are applied until proper disposition of a nonconformance, deficiency or unsatisfactory condition has been implemented. Duties Assessments (Vendor Audits, Surveillance) Regulatory compliance Document Control Nonconformance and Corrective Action tracking Perform other duties as assigned. Requirements High school graduate or equivalent (college, vocational or job training in a technical field preferred). 40-hour OSHA Hazwoper Certification with current 8-hr refresher. 16-hour radiation safety training with current 4-hour refresher. Auditor Annual respirator fit test qualified and ability to function in all levels of personal protective equipment (PPE). FORKLIFT OPERATOR SAFETY TRAINING General Safety Rules (SOP-001C) NNSS Site Requirements Training Hazmat Training QA Admin Level Training ISO 9001: 2015 REQUIREMENTS - QUALITY MANAGEMENT PAS LAB ETHICS AND DATA INTEGRITY TRAINING Hazmat Training RCRA Hazardous Waste Generator Training Receipt Inspector Attention to detail and organizational skills. Personality conducive to teamwork. Ability to follow written and oral directives. Written and verbal communication skills. Displays professionalism. Ability to multitask. Capacity to apply analytical evaluations to assigned work. Professional communications and organizational skills to conduct work independent of direct supervision Personality conducive to teamwork Detail oriented Working Conditions Continuous field/facility work required where there is potential for exposure to hazardous chemicals, radiation, noise, dust, and extreme temperatures. Climbing, walking and lifting will be normal daily requirements. Extensive travelling as required

Posted 3 weeks ago

Feld Entertainment logo

Qa/Compliance Administrator

Feld EntertainmentEllenton, FL
The QA/Compliance Administrator will take a proactive leadership role in ensuring compliance with industry standards and regulations. This position requires a strategic thinker who can assess compliance needs, make informed decisions, and implement solutions that enhance operational efficiency. The Compliance Administrator will oversee key compliance initiatives, manage critical communications, and drive data analysis and document management efforts. This role involves evaluating compliance procedures, recommending improvements, and enforcing policies to maintain regulatory standards and ensure organizational success. Essential Functions Lead Compliance Programs: Provide high-level oversight for the Code of Conduct program, ensuring all requirements are met. Identify compliance gaps, implement corrective actions, and enforce policies to maintain industry standards. Manage Supplier Training & Compliance- Lead training initiatives and collaborate with suppliers to ensure proper labeling and packaging of products in adherence to company standards. Proactively address non-compliance issues to uphold company requirements. Financial Compliance Management- Oversee invoice submissions to Accounts Payable, ensuring accuracy, compliance, and timely processing. Investigate and resolve discrepancies, making informed decisions to streamline payment operations. Data Oversight & Process Optimization- Analyze inspection and test reports to assess vendor and testing company compliance. Identify trends, recommend process improvements, and implement tracking enhancements to strengthen compliance initiatives. Strategic Compliance Leadership: Identify areas for operational improvement, develop recommendations, and implement decisions that enhance departmental efficiency and compliance effectiveness. Required Qualifications Bachelor's Degree in Business Administration or related field. Advanced expertise in Microsoft Excel, including skills in functions such as VLOOKUP, PivotTables, and data analysis tools, is required to support quality assurance reporting and data management tasks. Strong Excel expertise is essential for success in this role, as it underpins critical QA processes and decision-making. Strong Decision-Making Skills: Ability to assess compliance situations and make effective administrative and procedural decisions. Exceptional Communication Abilities: I have excellent written and verbal communication skills for engaging with internal teams, clients, and regulatory bodies. Detail-Oriented Leadership: Strong organizational skills with the ability to simultaneously meet firm deadlines and oversee multiple compliance initiatives. Time Management & Prioritization: Ability to effectively prioritize tasks and manage complex workflows. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Posted 30+ days ago

Ivy Rehab logo

Patient Engagement Center QA Manager

Ivy RehabHouston, TX
State of Location: Texas Position Summary: At Ivy Rehab, we're "All About the People"! As a Call Center / Patient Engagement Center QA Manager, you will play a crucial role in our mission to help enable people to live their lives to the fullest. Join Ivy Rehab's dedicated team where you're not just an employee, but a valued teammate! Together, we provide world-class care in physical therapy, occupational therapy, speech therapy, and applied behavior analysis (ABA) services. Our culture promotes authenticity, inclusion, growth, community, and a passion for exceptional care for every patient. Job Description: OUR VALUES: One Ivy- Love what you do- Do the right thing- I belong- GSD (Get stuff done) - Grow- Serve others The Patient Engagement Center QA Manager will develop and lead the Quality Assurance (QA) program for our Patient Engagement Center (PEC) by evaluating patient interactions, collecting and analyzing data to improve processes and protocols within the contact center, finding coaching opportunities, and helping Patient Engagement Advocates improve their skills. In this role, the PEC QA Manager will be responsible for ensuring that PEC team members are properly and effectively handling a variety of interactions, ranging from scheduling/changing new patient appointments, to general questions, to complaints. Over time, the PEC will also handle other interaction channels, such as outbound, chat, email. The PEC QA Manager will ensure that team members can resolve issues quickly and effectively, de-escalate challenging situations, and provide an exceptional patient experience. Your responsibilities will include: Design and develop our quality assurance program by setting clear and measurable standards that align with the PEC's goals and ensure a consistent and quality approach to handling patient interactions Regularly monitor and conduct evaluations of interactions to assess the quality of service and identify strengths and areas for improvement in Advocate performance Provide in-the-moment coaching to Advocates to improve their performance as measured against KPIs Lead the "nesting" program when Advocates graduate training and begin handling interactions Collaborate with other Ivy departments to ensure process alignment among the PEC, front office, and clinic teams to meet quality standards for all departments involved in patient interactions Observe daily operations of the contact center and lead interaction quality calibrations to identify skill gaps and necessary training program improvements Evolve QA program (materials, modalities, processes) with growth of contact center Develop strategies to improve PEC KPIs and create reporting structure to share performance trends, areas of concern, and opportunities for improvement with Advocates and PEC management To excel in this role, you should possess: Undergraduate degree and minimum 3-5 years quality assurance experience in a contact center environment Empathy and coaching abilities to provide feedback that is not only constructive but also supportive Excellent problem-solving and analytical skills to not only identify issues but offer innovative solutions Healthcare/physical therapy experience a plus Knowledge of customer service best practices Detail-oriented, self-reliant, and process-driven mindset Strong communication (verbal and written), interpersonal, and conflict resolution skills Ability to provide leadership to team members in a fast-paced and stressful work environment Must be technically savvy, with demonstrated experience working with multiple systems and apps Why choose Ivy? Best Employer: A prestigious honor to be recognized by Modern Healthcare, signifying excellence in our industry and providing an outstanding workplace culture. Exceeding Expectations: Deliver best-in-class care and witness exceptional patient outcomes. Incentives Galore: Eligibility for full benefits package beginning within your first month of employment. Generous PTO (Paid Time Off) plans and paid holidays. Exceptional Partnerships: Collaborate with leaders like Hospital for Special Surgery (HSS) and educational partners for continuous learning. Empowering Values: Live by values that prioritize teamwork, growth, and serving others #LI-remote #LI-ST1 We are an equal opportunity employer, committed to diversity and inclusion in all aspects of the recruiting and employment process. Actual salaries depend on a variety of factors, including experience, specialty, education, and organizational need. Any listed salary range or contractual rate does not include bonuses/incentive, differential pay, or other forms of compensation or benefits. ivyrehab.com

Posted 5 days ago

I logo

Incog Biopharma Services Careers - Senior QA Specialist, 2Nd Shift

INCOG BioPharmaFishers, IN
Senior Quality Assurance Specialist Summary Working closely with the QA Manager, the Senior QA Specialist will be instrumental in supporting major QA programs. They will also be key in championing and progressing the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The Senior QA Specialist will at all times provide support with identifying and closing Operational and Quality gaps. The Senior Quality Assurance Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. The Senior QA Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Senior QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Senior QA Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Review and approve documentation for Quality approval, including but not limited to: components/raw materials, batch records, change control requests, deviations and validation documents, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Prioritize and coordinate his/her time in balancing production timelines with product quality assurance. Perform electronic and physical release of raw materials, components, sterile consumables, media, etc. Own and maintain the reference sample program. Collaborate with Facilities Engineering and oversee the site's pest control program. Support batch record review and disposition. Mentor other QA Associates on the shift. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, laboratory instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology, etc.) Minimum of 8 years of experience working in a GMP manufacturing environment. Minimum of 4 years experience of QA oversight for GMP manufacturing. 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required. Extensive knowledge of regulations and quality processes involving product disposition. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing Quality. Hands-on experience with manual visual inspection. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

V logo

QA Document Control And Training Specialist

Vera Therapeutics Inc.Brisbane, CA

$90,000 - $115,000 / year

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com. Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: QA Document Control and Training Specialist will report to the Senior Director, Quality Systems and Compliance and will be responsible for overseeing the day-to-day operations of the Document Control and Training systems. This role requires close collaboration with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards. The ideal candidate will be a proactive subject matter expert (SME) with proven experience in managing document lifecycle processes, training programs, and quality systems within a pharmaceutical or regulated environment. Responsibilities: Document Control Management: Work closely with stakeholders to create, format, and manage controlled documents and templates within the electronic Document Management System (eDMS). Oversee the entire document lifecycle, including creation, routing, review, approval, periodic review, and archival to maintain data integrity and compliance. Manage document retention program and associated records and ensure proper archiving and retrieval processes are in place. Troubleshoot document issues within Microsoft Suite applications (e.g., Word, Excel) and PDF (e.g., Adobe Acrobat). Training Program Oversight: Support GxP training initiatives within the organization, acting as a Subject Matter Expert (SME) for training programs. Ensure training content is developed, maintained, and assigned appropriately in the electronic Learning Management System (eLMS). Qualifications: BA/BS degree in a related field or equivalent experience. 2+ years of relevant experience in a regulated environment, preferably within a QA. Strong understanding of FDA, ICH, and international pharmaceutical regulations and guidelines. In-depth understanding of Good Documentation Practices (GDocP) and ALCOA++ Hands-on experience administering eDMS and Experience with Veeva is a plus. Advanced Proficiencies in Microsoft Word (formatting, templates, forms, embedded hyperlinks), Microsoft Excel, and Adobe Acrobat are a must. Experience supporting audits and regulatory inspections with strong knowledge of data integrity and compliance best practices is a plus. Demonstrated ability to work independently and cross-functionally, building relationships with key stakeholders. Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment. Excellent communication, problem-solving, and issue resolution skills. Vera Therapeutics Inc. is an equal-opportunity employer. Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience. For this role, the anticipated base pay range is $90,000-$115,000 USD Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Vera Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/ . Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.

Posted 2 weeks ago

Guardian Life logo

Senior QA Engineer

Guardian LifeNew York, NY

$118,980 - $195,465 / year

Senior QA Engineer As a Senior QA Engineer, your role will be to promote product ownership and quality through well-defined measurable processes, comprehensive quality assessment and identification of risk. You will be embedded within our Application and Platform Engineering teams, working closely with Product and Design to understand features, bugs, customer usage, and technical implementation to deliver high quality products for our customers. You will play an integral part in helping us shift testing left in our SDLC and finding the right tools for it. What You'll Do: Drive the creation and execution of test strategy, test plans, test cases as well as utilize automated tools to optimize the SDLC/STLC Perform exploratory testing, automate repetitive tasks and work side-by-side with software development engineers Review user interfaces for conformity and functionality Efficiently execute test cases across all functional and UI areas of our products Find, isolate, document, regress, and track bugs through resolution Measure, interpret and report testing results, and be a vocal proponent for quality in every phase of the development process What You'll Bring to the Table: 4+ years of experience working as a Quality Assurance Engineer Hands-on experience creating, executing and maintaining test automation (Javascript preferred) Experience in testing and test automation solutions spanning front-end UI to APIs Understanding of continuous integration and associated tools and processes Ability to communicate cross-functionally and across levels in formal and informal settings, clearly articulating technical concepts with the ability to thoughtfully defend one's stance against disagreement or skepticism Must be able to thrive in an ambiguous environment - where change is the only constant Must be an effective multi-tasker comfortable working on multiple products and projects Team-oriented mindset, celebrating and taking joy in the success of others on the team Experience in a startup or venture-like operating model preferred Salary Range: $118,980.00 - $195,465.00 The salary range reflected above is a good faith estimate of base pay for the primary location of the position. The salary for this position ultimately will be determined based on the education, experience, knowledge, and abilities of the successful candidate. In addition to salary, this role may also be eligible for annual, sales, or other incentive compensation. Our Promise At Guardian, you'll have the support and flexibility to achieve your professional and personal goals. Through skill-building, leadership development and philanthropic opportunities, we provide opportunities to build communities and grow your career, surrounded by diverse colleagues with high ethical standards. Inspire Well-Being As part of Guardian's Purpose - to inspire well-being - we are committed to offering contemporary, supportive, flexible, and inclusive benefits and resources to our colleagues. Explore our company benefits at www.guardianlife.com/careers/corporate/benefits. Benefits apply to full-time eligible employees. Interns are not eligible for most Company benefits. Equal Employment Opportunity Guardian is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, race, color, creed, religion, sex, affectional or sexual orientation, national origin, ancestry, marital status, disability, military or veteran status, or any other classification protected by applicable law. Accommodations Guardian is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. Guardian also provides reasonable accommodations to qualified job applicants (and employees) to accommodate the individual's known limitations related to pregnancy, childbirth, or related medical conditions, unless doing so would create an undue hardship. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact MyHR@glic.com. Please note: this resource is for accommodation requests only. For all other inquires related to your application and careers at Guardian, refer to the Guardian Careers site. Visa Sponsorship Guardian is not currently or in the foreseeable future sponsoring employment visas. In order to be a successful applicant. you must be legally authorized to work in the United States, without the need for employer sponsorship. Current Guardian Colleagues: Please apply through the internal Jobs Hub in Workday.

Posted 4 days ago

DPR Construction logo

Taxonomy Qa/Qc Support Admin - OES

DPR ConstructionLorton, VA
Job Description The Taxonomy QA/QC Support Admin is a data‑driven support role that plays a key part in maintaining the accuracy and integrity of the Taxonomy team's product lifecycle management data. This position supports the end‑to‑end Taxonomy process by assisting with item mapping, validation, research, and quality control efforts across multiple data platforms. The ideal candidate is highly organized, detail‑oriented, and comfortable working with structured data to ensure all items are accurately researched, mapped, and maintained throughout the Taxonomy project lifecycle. Duties and Responsibilities Responsible for item mappings within the Taxonomy project. Primary focus on items for vendors that have initially passed through and were reviewed by QA/QC. Would review items via PowerBi, Sharepoint, and/or Excel. Responsible for item mapping for items from the Family of Companies. Weekly report from SPD & DBC via excel. Assist with the QA/QC of new items brought in through the Taxonomy project. Responsible to create new items as necessary and update all Taxonomy files. Support issue resolution as necessary. Expected to be involved and participate in team meetings, virtually or in person. Additional ad-hoc responsibilities as necessary. Required Skills and Abilities Proficient in Excel Strong organization skills and attention to details. Excellent written and verbal communication skills. Experience with Microsoft platforms. Education and Experience Experience in the Construction Industry. Experience with PLM. Experience with Construction related products. Physical Requirements Full time in office expected. Prolonged periods sitting at a desk and working on a computer. DPR Construction is a forward-thinking, self-performing general contractor specializing in technically complex and sustainable projects for the advanced technology, life sciences, healthcare, higher education and commercial markets. Founded in 1990, DPR is a great story of entrepreneurial success as a private, employee-owned company that has grown into a multi-billion-dollar family of companies with offices around the world. Working at DPR, you'll have the chance to try new things, explore unique paths and shape your future. Here, we build opportunity together-by harnessing our talents, enabling curiosity and pursuing our collective ambition to make the best ideas happen. We are proud to be recognized as a great place to work by our talented teammates and leading news organizations like U.S. News and World Report, Forbes, Fast Company and Newsweek. Explore our open opportunities at www.dpr.com/careers.

Posted 4 days ago

DPR Construction logo

Taxonomy Qa/Qc Admin

DPR ConstructionAtlanta, GA
Job Description The Taxonomy QA/QC Admin - OES Equipment role is a data‑driven position that plays a critical role in the accuracy, consistency, and overall success of the Taxonomy team. This role is responsible for supporting the end‑to‑end Taxonomy process by mapping, creating, validating, and researching new items, with a strong focus on quality assurance and quality control. The ideal candidate is highly detail‑oriented, organized, and comfortable working across multiple data platforms to ensure items are accurately classified and maintained throughout all stages of the Taxonomy project. Duties and Responsibilities Responsible for the QA/QC of new items for the Taxonomy project. Focus on new vendors and items for the Taxonomy project. Would review the items via PowerBi, Sharepoint, and/or Excel. Responsible to research and ensure that items are mapped properly through all stages of the Taxonomy project. Responsible to find, research, and resolve issues as necessary. Responsible to create new items as necessary and update all Taxonomy files. Expected to be involved and participate in team meetings, virtually or in person. Additional ad-hoc responsibilities as necessary. Required Skills and Abilities Proficient in Excel. Strong organization skills and attention to details. Excellent written and verbal communication skills. Experience with Microsoft platforms. Education and Experience Experience in the Construction Industry. Experience within Smartsheets. Experience within RentalMan. Experience with Construction related products. Physical Requirements Full time in office expected. Prolonged periods sitting at a desk and working on a computer. DPR Construction is a forward-thinking, self-performing general contractor specializing in technically complex and sustainable projects for the advanced technology, life sciences, healthcare, higher education and commercial markets. Founded in 1990, DPR is a great story of entrepreneurial success as a private, employee-owned company that has grown into a multi-billion-dollar family of companies with offices around the world. Working at DPR, you'll have the chance to try new things, explore unique paths and shape your future. Here, we build opportunity together-by harnessing our talents, enabling curiosity and pursuing our collective ambition to make the best ideas happen. We are proud to be recognized as a great place to work by our talented teammates and leading news organizations like U.S. News and World Report, Forbes, Fast Company and Newsweek. Explore our open opportunities at www.dpr.com/careers.

Posted 4 days ago

Bristol Myers Squibb logo

Senior Specialist, QA Shop Floor, Cell Therapy In Devens, MA

Bristol Myers SquibbDevens, MA
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The Senior Specialist, Quality Assurance Shop Floor, Cell Therapy position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions. The Senior Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, deviation triage and determination. Participation in cross-functional triage meetings. They own; review or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, the incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed. Shifts Available: A1 & B1- 6am- 6pm, rotational schedule including holidays and weekends Responsibilities: Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management. May perform and document operational verification per approved procedures. Develops, reviews and/ or approves temporary and non routine procedure for event response. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans. Own actions for departmental programs and propose improvements to programs. Communicate and resolve discrepancies independently and escalate as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel. May own training curriculum and content. Independently assess discrepancies for entry into quality system and approve records as applicable. Lead meetings and represent function at cross functional meetings. Share data/knowledge within and across team. Build & maintain strong relationships with partner functions. May prioritize and assign tasks for the team. Observe operations occurring on the floor and proactively identify risks and drive improvements. Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals. Able to influence others based on time and task commitments, organize/run meetings. Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.). Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting. Knowledge and Skills: Ability to research, understand, interpret and apply internal SOP's, policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications. Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills and ability to present technical data effectively based on target audience. Ability to work in a fast-paced team environment and lead peers through changing priorities. Detail oriented and task focused with ability to meet deadlines and support work prioritization. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Demonstrated experience with quality management systems Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Basic Requirements: Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens- MA - US: $89,780 - $108,789 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/ . Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1596913 : Senior Specialist, QA Shop Floor, Cell Therapy in Devens, MA

Posted 1 week ago

Xealth logo

Manual QA Engineer

XealthSeattle, WA

$90,000 - $125,000 / year

About the Role As a Manual QA Engineer at Xealth, you will provide comprehensive QA coverage across a multitude of product areas including: web and mobile applications, APIs, data pipelines, and AI outputs. In doing so, you will develop and execute test strategies, identify defects early in the development lifecycle, and work collaboratively with Product and Engineering teams to drive high-quality releases in a fast-paced healthcare environment. This role will also define acceptance criteria, maintain testing standards, and continuously contribute to, and improve, Xealth's automated regression test framework. Key Responsibilities Own end to end testing for assigned Xealth features from requirement analysis through release. Create, maintain, and execute feature-level test plans, including functional, regression, negative and edge-cases scenarios. Develop integrated test scripts and collaborate with the team to review and uphold testing standards while ensuring comprehensive coverage. Identify and manage dependencies across services, integrations, and end-to-end workflows. Review logs to ensure there are no errors on the Xealth side leading up to go live. Identify, create, regress, and track defects through resolution in Jira. Proactively identify testing or monitoring gaps and collaborate with the team to resolve them. Validate error handling, alerts, and safeguards to ensure system reliability. Demonstrate proficiency in using internal tools and complete tasks independently. Oversee and contribute to regression testing efforts and share them to continuously enhance automation coverage. Validate HL7, API, and FHIR message flows for clinical use cases where applicable. Post Implementation testing/monitoring. Perform post-implementation testing and monitoring to ensure released features function as intended and meet quality standards. Lead the investigation and resolution of production issues, ensuring timely mitigation and verification. Conduct a daily review of logs/metrics & alerts following go-live to confirm feature stability and identify anomalies. Communicate with the support team regarding any Production issues. Execute and monitor production regression tests for any alerts post implementation. Preferred Skills: Passion for improving healthcare outcomes through technology. 4+ years hands-on QA engineering or software testing experience. Experience utilizing AI tools to improve QA productivity. Experience building test plans and test cases for features testing. Working knowledge of HTML, CSS, and JavaScript for testing and troubleshooting web applications. Some familiarity with AWS tools is preferred. Strong analytical, troubleshooting, and problem-solving skills. Hands-on experience with testing browser-based web applications and RESTful APIs using Postman. Experience using QA tools including JIRA, TestRail, Confluence, and BrowserStack. Experience testing healthcare applications, clinical workflows, or HL7/FHIR integrations preferred. Familiarity with agile methodologies, sprint planning, and CI/CD workflows. Bachelor's degree or equivalent professional experience. About Xealth Xealth created the leading digital health platform helping health systems deliver connected, personalized care at scale. Embedded in the EHR, it enables clinicians to prescribe, automate, and measure the impact of digital tools--including apps, services, and wearable data--within existing workflows. Now part of Samsung's connected care vision, Xealth enhances decision-making, reduces friction, and supports enterprise-wide digital health strategies. Trusted by more than 500 hospitals and 70+ solution partners, Xealth provides a scalable foundation for delivering connected, personalized, and preventative care--empowering health systems to drive outcomes, engagement, and operational efficiency while advancing digital transformation. Xealth has been named to the World's Best Digital Health Companies list by Newsweek, awarded gold in the Digital Health awards in 2024 and twice in 2023. In 2023 Xealth was also listed as one of BuiltIn's Best Places to Work, and one of Fierce Healthcare's Fierce 15 of 2023. Compensation and Benefits: Xealth offers a multi-tiered approach when constructing a highly competitive compensation package. The compensation package would include a base salary, bonus, and a comprehensive suite of benefits. The base salary compensation range for this position is $90,000 - $125,000, depending on geographic market. Paid parental leave. Comprehensive medical, dental, and vision policies. Xealth covers 100% of employee premiums. We also provide Employee Assistance Programs. Xealth provides your laptop and offers a home office stipend. Generous learning & development opportunities for you to grow your skills and career. 401k Match: Xealth offers a dollar-for-dollar match up to 3%. Flexible time off & 10 standardized holidays. $500 yearly fitness stipend to spend on staying active. Xealth is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures.

Posted 1 week ago

A logo

QA Engineering Intern

Asset MarkCharlotte, NC

$25+ / hour

Job Description: AssetMark is a leading strategic provider of innovative investment and consulting solutions serving independent financial advisors. We provide investment, relationship and practice management solutions that advisors use in helping clients achieve wealth, independence and purpose. The Quality Assurance (QA) Intern will be part of a small, collaborative team focused on delivering critical functionality for one or more products at AssetMark. Throughout the internship, the individual will gain hands-on experience across both application and /or platform layers. The QA Intern will work under the guidance of an experienced Quality Assurance Engineering leader with deep expertise in various facets of quality analysis and testing. We can consider candidates for this position who are able to accommodate a hybrid work schedule and are close to our Charlotte, NC office. Responsibilities: Execute manual test cases accurately and document defects with clear reproduction steps Perform manual regression testing across multiple features and environments Identify basic functional defects and communicate findings effectively Document test results clearly and provide accurate test status updates Use test management tools effectively to track testing progress Knowledge, Skills, Abilities: Understand basic testing principles and methodologies Participate in test case reviews and contribute to testing discussions Understand system architecture and testing approaches. Working knowledge in any of the technologies, such as Playwright, Python, Jira, X-Ray, and TypeScript. Exposure to BDD framework tools such as Cucumber Exposure to the Azure cloud computing environment, Visual Studio code Familiarity with Azure GIT Repos, branching mechanism and Deployment pipelines. Familiarity with iterative development methodologies. Excellent communication skills, both verbal and written Excellent analytical and problem-solving abilities Ability to adapt and learn new technologies and automation frameworks quickly Financial Services industry knowledge Education & Experience: Currently pursuing a Bachelor's or Master's degree in Computer Science, Computer Engineering, Information Technology, or a related technical field 1-2 years of programming experience through coursework, academic projects, or relevant hands-on experience Strong academic standing with a minimum GPA of 3.0 on a 4.0 scale Internship Details: Hourly wage: $25.00 per hour Internship Duration: June 8th- August 14th Candidates must be legally authorized to work in the US to be considered. We are unable to provide visa sponsorship for this position. #LI-TN1 #LI-hybrid Who We Are & What We Offer: We are AssetMark, a company on the move, shaping the future of financial services. Growth is in our DNA. Every day, we combine technology, insight, and collaboration to create new possibilities for advisors, for our people and for our investors. At AssetMark your ideas matter; they're heard, valued, and drive meaningful change. Join a team that sets new standards and creates space for you to thrive and do your best work. Our Mission Our mission is simple: to help our 10,500+ financial advisors make a meaningful difference in their clients' lives. We do this by combining powerful technology, holistic support, and expert consulting to help advisors run stronger, more efficient businesses. Backed by a comprehensive suite of investment solutions and a trust company that boasts of $150B+ AUM, our platform empowers advisors to deliver exceptional service and an outstanding client experience. Our Values Heart. Client Success. Integrity. Respect. Excellence. Our values are how we show up every day. We believe in: Leading with Heart, in truly making a difference in the lives of others: teammates, clients, investors and communities. Obsessing over Client Success, bringing a relentless focus on what matters to clients that sets us apart and creates loyal, lasting relationships. Unyielding Integrity, doing what's right, always. Even when it's hard. Collective Respect, in being authentic, inclusive and valuing all voices while winning together. Operating with Excellence, in learning fast, continuously improving, innovating and collaborating to find new and better solutions. These values shape our culture, guide our decisions, and define what it means to be part of the AssetMark family. Our Culture & Benefits Our culture brings our mission and values to life. Here, we do what's right, embrace diverse ideas, and innovate together. We also offer a wide range of benefits to support you and your family-because thriving at work starts with thriving in life. Flex Time or Paid Time Off and Sick Time Off 401K - 6% Employer Match Medical, Dental, Vision- HDHP or PPO HSA - Employer contribution (HDHP only) Volunteer Time Off Career Development / Recognition Fitness Reimbursement Hybrid Work Schedule As an Equal Opportunity Employer, AssetMark is committed to building a diverse and inclusive workplace where everyone feels valued.

Posted 1 week ago

Aviagen logo

QA Coordinator

AviagenElkmont, AL
Job Description Summary: We are seeking an outstanding individual to fill the position of Quality Assurance Coordinator at Aviagen's GGP Hatchery in Elkmont, AL. This role is a critical part of the Hatchery team to ensure Aviagen's quality objectives are maintained and to verify conformance of activities to quality assurance standards. This position will work closely with the GGP Hatchery and production teams and will report directly to the GGP QA and Regulatory Manager. Job Description: The ideal candidate should have the following experience, skills, and attributes: Bachelors of Science or equivalent preferred. Strong computer skills including Microsoft Excel (with Pivot Tables), PowerPoint, and Word. Must be able to perform occasional physically demanding aspects of the job. Able to work flexible hours and weekends. Above average math skills and problem-solving abilities, with an emphasis on data collection and analysis. Knowledge of hatchery and poultry operations preferred. Knowledge and familiarity with sampling procedures to include bacterial and mold monitoring. Detail oriented, professional, strong organizational skills, and self-motivated. Preferred understanding of ISO 9001:2015 or equivalent. Preferred knowledge of hatchery and poultry operations. Key Responsibilities: The following duties will vary according to the needs of the organization. Normal duties will include, but are not limited to, the following: Quality assurance checks on day old chicks and eggs. Assist in revising and updating the quality assurance manual and procedures. Observe and ask employees questions pertaining to job functions. Maintain strong communication with the GGP Hatchery management team, and interact and communicate with all levels of facility personnel. Read processing information such as worker logs, product processing sheets, and specification sheets to verify that records adhere to quality assurance specifications. Aptitude to determine appropriate corrective actions and root cause analysis. Perform routine facility monitoring, tests, and sample collection. Interact and communicate with all levels of hatchery personnel. Recognize problems and opportunities for improvement that may affect quality, and aid in coming up with and implementing solutions (determine appropriate corrective actions and root cause analysis). Write and submits report to hatchery supervisory personnel and QA Management team. Maintain and upload paperwork in a timely manner. Follow policies and procedures related to animal welfare, biosecurity, and compartmentalization. Other duties as determined by QA Management team. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Posted 30+ days ago

E logo

Senior Operations QA Clinical GLP Manager

Exelixis Inc.Alameda, CA

$165,000 - $235,000 / year

SUMMARY/JOB PURPOSE: The Senior Operations QA Clinical GLP Manager is accountable for assisting in the development, implementation and maintenance of end-to-end QA processes and activities, including GLP operations. Provide Operations QA oversight of day-to-day end-to-end (Drug Substance, Drug product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, and managing product complaints. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on the company core goals and pipeline deliverables. Manages Exelixis partnerships, collaborations. audits, forges strong relationships to maintain performance and continuous improvement. Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with GLP regulations, biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. ESSENTIAL DUTIES/RESPONSIBILITIES: Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP and GLP issues). Develop, implement, and continuously improve QA programs, policies and procedures to ensure GMP and GLP compliance of clinical trial material, and onsite labs. Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment, and review of GLP documents and records. Oversee CMOs and GLP vendors, as applicable: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues. Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, GLP documents and records, etc.) Responsible for developing, tracking and managing periodic management reports, including key GMP and GLP compliance and QA metrics, as applicable. Maintain and report CMO metrics and Operations QA metrics. Evaluate and generate data to support KPIs (Key Performance Indicators). Identify and rapidly mitigate risk. Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented. Contribute to APQR (annual product quality review) as applicable. Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs and GLP. Partners with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, PSC Analytical, and R&D as it pertains to GLP, etc., regarding compliance issues, provides compliance guidance to all audited parties. Maintains knowledge of current regulation requirements; informs stakeholders of potential impact on the organization. Deliver per supply plans, drive results. SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or, PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or, Equivalent combination of education and experience. Experience: A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred Two years' experience managing Contract Manufacturing Organizations preferred Five years general experience in biotech/pharmaceutical industry. Experience in development of metrics and continuous improvements is preferred Knowledge, Skills and Abilities: Demonstrated knowledge of the drug development processes Demonstrated GLP audit conduct and management experience is required. Working knowledge of supporting GLP preparation and submission activities for global regulatory filings. Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines. Proven experience in a virtual manufacturing environment or relevant industry/profession. Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, laboratory practices and tox studies, and understanding of the international regulatory landscape. Small molecule, oral solid form, biologics technical knowledge required. Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways. Implements technical solutions within quality requirements to complex problems. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Great attention to detail. Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics. Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization. Excellent MS Office, Word, Excel and PowerPoint skills. Work Environment/Physical Demands: This is an onsite position Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. This position requires up to 5% travel. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $165,000 - $235,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Posted 30+ days ago

I logo

Incog Biopharma Services Careers - QA Associate, 3Rd Shift

INCOG BioPharmaFishers, IN
Working closely with the QA Operations Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Support other QA personnel with batch record reviews, material release, etc. Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Must pass health and visual checks and eye inspections annually. Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing. Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 2 weeks ago

Nvidia logo

Senior Software QA Test Development Engineer - Diagnostics

NvidiaSanta Clara, CA

$140,000 - $224,250 / year

NVIDIA is the world leader in GPU Computing. We are passionate about markets include gaming, automotive, vision, HPC, datacenters and networking in addition to our traditional OEM business. NVIDIA is also well positioned as the 'AI Computing Company', and NVIDIA GPUs are the brains powering Deep Learning software frameworks, analytics, data centers, and driving autonomous vehicles. We have some of the most experienced and dedicated people in the world working for us. If you are dedicated, forward-thinking, and hard-working technical people across countries sounds exciting, this job is for you. NVIDIA is looking for an outstanding individual who thrives in a diverse work environment, has outstanding interpersonal skills and possesses a strong sense of engagement and continuous process improvement. This candidate must have enterprise server integration, strong Linux experience, reliability testing with various telemetries, scale out cluster, test plan development, track record in developing AI tools and NLP, DevOps, CI/CD experience to join our platform SWQA team. What you'll be doing: Responsible for the development and execution of NVIDIA HGX/DGX/MGX platform test plan on servers, OS, FW and CUDA SW stack from design doc. Installing and testing various systems OS, server firmware and SW stack. Drive support for root cause analysis on reliability and validation test failures to identify root cause(s) and achieve mitigation. Build, develop/debug server and OS level automation front-end and back-end framework and tests Review partner and supplier test results and prescribe additional reliability testing on components, servers, and packaging as needed. Work in an agile software development team with very high production quality standards. Manage bug lifecycle and collaborate with inter-groups to drive for solutions. What we need to see: Bachelor's Degree (or equivalent experience) in a STEM (Science, Technology, Engineering, Math or Physics) field 5+ years proven experience; or master's degree. Proven years of OS and server level automation, CI/CD process and DevOps experience using Python, SHELL, Ansible, Jenkins, C/C++, Java, JavaScript Strong server and Linux(Ubuntu, RedHat, CentOS, SuSE, Fedora and etc…) troubleshooting and debugging experience in a bare-metal and KVM/VMWare/Hyper-V environment. Good knowledge and hands-on experience in model testing, AI tools/frameworks (TensorFlow, Pytorch, Cursor and etc…), NLP and LLM benchmarking Experience in using AI development tools for test plans creation, test cases development and test cases automation Strong experience in FW, BMC/OpenBMC, Network protocol, internal/external enterprise storage devices, PCIe buses and devices, IO sub-devices, CPU and memory, ACPI, UEFI spec, Redfish - huge plus Proven years of experience in GitHub/Gitlab/Gerrit, PXE, SLURM, Stack/Kubernetes/Docker) - huge plus Ways to stand out from the crowd: AI related tools, LLM and NLP. Experience working with NVIDIA GPU hardware is a strong plus. Good to have solid understanding of virtualization in Linux (KVM, Docker orchestrated with Kubernetes) Background in parallel programming ideally CUDA/OpenCL is a plus Your base salary will be determined based on your location, experience, and the pay of employees in similar positions. The base salary range is 140,000 USD - 224,250 USD for Level 3, and 168,000 USD - 270,250 USD for Level 4. You will also be eligible for equity and benefits. Applications for this job will be accepted at least until January 14, 2026. This posting is for an existing vacancy. NVIDIA uses AI tools in its recruiting processes. NVIDIA is committed to fostering a diverse work environment and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) on the basis of race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.

Posted 30+ days ago

DPR Construction logo

Taxonomy Qa/Qc Support Admin - OES

DPR ConstructionOES - Dallas-Fort Worth, TX
Job Description The Taxonomy QA/QC Support Admin is a data‑driven support role that plays a key part in maintaining the accuracy and integrity of the Taxonomy team's product lifecycle management data. This position supports the end‑to‑end Taxonomy process by assisting with item mapping, validation, research, and quality control efforts across multiple data platforms. The ideal candidate is highly organized, detail‑oriented, and comfortable working with structured data to ensure all items are accurately researched, mapped, and maintained throughout the Taxonomy project lifecycle. Duties and Responsibilities Responsible for item mappings within the Taxonomy project. Primary focus on items for vendors that have initially passed through and were reviewed by QA/QC. Would review items via PowerBi, Sharepoint, and/or Excel. Responsible for item mapping for items from the Family of Companies. Weekly report from SPD & DBC via excel. Assist with the QA/QC of new items brought in through the Taxonomy project. Responsible to create new items as necessary and update all Taxonomy files. Support issue resolution as necessary. Expected to be involved and participate in team meetings, virtually or in person. Additional ad-hoc responsibilities as necessary. Required Skills and Abilities Proficient in Excel Strong organization skills and attention to details. Excellent written and verbal communication skills. Experience with Microsoft platforms. Education and Experience Experience in the Construction Industry. Experience with PLM. Experience with Construction related products. Physical Requirements Full time in office expected. Prolonged periods sitting at a desk and working on a computer. DPR Construction is a forward-thinking, self-performing general contractor specializing in technically complex and sustainable projects for the advanced technology, life sciences, healthcare, higher education and commercial markets. Founded in 1990, DPR is a great story of entrepreneurial success as a private, employee-owned company that has grown into a multi-billion-dollar family of companies with offices around the world. Working at DPR, you'll have the chance to try new things, explore unique paths and shape your future. Here, we build opportunity together-by harnessing our talents, enabling curiosity and pursuing our collective ambition to make the best ideas happen. We are proud to be recognized as a great place to work by our talented teammates and leading news organizations like U.S. News and World Report, Forbes, Fast Company and Newsweek. Explore our open opportunities at www.dpr.com/careers.

Posted 4 days ago

L logo

Sr. QA Validation Specialist, CSV & Equipment

Legend Biotech CorpRaritan, NJ

$123,605 - $162,232 / year

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. QA Validation Specialist, CSV & Equipment as part of the Quality team based in Raritan, NJ. Role Overview The Sr. QA Validation Specialist, CSV & Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity. Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site Review and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration). Provide expertise and solutions to issues regarding qualification and validation strategies and documentation. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems. Assist in the development of validation and qualification related policies, procedures, templates, forms. Provides quality oversight on data integrity of systems, instruments, and equipment used at the site. Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations. Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site. Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous improvement. Provide training and guidance to other members of the team. Other duties may be assigned, as necessary. Requirements A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required. 7+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus. Strong knowledge of GxP compliance. Experience in cGMP regulatory body audits. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Experience reviewing/auditing GMP documentation. Strong proficiency with using Microsoft Office applications. #Li-RP1 #Li-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is: $123,605-$162,232 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Posted 30+ days ago

KITE PHARMA, INC. logo

QA Specialist III

KITE PHARMA, INC.Santa Monica, CA

$107,185 - $138,710 / year

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Overview

Schedule
Full-time
Career level
Senior-level
Remote
On-site
Compensation
$107,185-$138,710/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance

Job Description

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

We are seeking a highly motivated individual contributor to join us as a QA Specialist III within External Quality embedded within Kite's External Quality Organization. The QA Specialist III will report to the Quality Director, External Quality. Scope of the External Quality group includes quality oversight of contracted service providers such as development and manufacturing organizations(CMO/CDMO), contract testing labs (CTLs) and quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space.

The QA Specialist III will have opportunities to work and share knowledge with partners across Kite's Global Technical Operations (e.g. Quality Control, Analytical Development, Process Development, Quality, Manufacturing, Supply Chain, and Regulatory) as well as international partners. The ideal candidate will have strong technical skills (knowledge of one or more of the following: cell therapy, bioassays, viral vector, and testing operations), Quality and Compliance background (Biologics, Drug, regulation), and understanding of the drug development lifecycle.

This position will be based at Kite's headquarters in Santa Monica, CA.

Responsibilities of the QA Specialist III include:

  • Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities.

  • Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records, investigations, corrective actions, change controls, protocols and reports, annual product quality reviews, IND/BLA/MAA CMC modules, Quality Agreements.

  • Compilation of critical material and product disposition packages. Project management of disposition deliverables (e.g. investigations, batch records) ensuring timely critical material and/or product supply.

  • Perform disposition (release) of product from CMOs.

  • Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kite's CMOs.

  • Assist, gather and analyze information to support External Supply Quarterly Management Review, provide mitigation plans for issues and risks.

  • Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations.

  • Up to 10% travel (domestic)

Basic Qualifications:

  • Master's Degree and 3+ years' experience in GMP environment related field OR

  • Bachelor's Degree and 5+ years' experience in GMP environment related field

Preferred Qualifications:

  • Working with or at contract manufacturing or testing organizations or supporting partnerships.

  • Diplomacy skills and ability to assess performance and proactively identify and mitigate risks

  • Experience with collaborating in a cross-functional working model with support from fully-and partially dedicated resources; ability to manage through influence.

  • Experience with direct FDA interaction (or other regulatory agencies)

  • Experience writing, evaluating and closing investigations, CAPAs and change control records.

  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies

  • Excellent oral and written communication skills

  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

  • Previous experience in Quality Control, Quality Assurance or Analytical Science

People Leader Accountabilities:

  • Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

  • Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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