Top QA Jobs Hiring Now - Apply with AI Matching

We've scanned millions of jobs. Simply select your favorites, and we can fill out the applications for you.

Genentech logo
GenentechHillsboro, Oregon

$77,000 - $174,000 / year

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO produces millions of units of life-saving medicine every year for patients around the world. The Opportunity: In this exciting role, you will be part of a dynamic and inclusive team. You will act as lead investigator for complaints, critical deviations and the associated escalation process.You will be a mentor and coach for the organization and the network and you will provide quality oversight for our commercial production and the complaints at the Hillsboro site. You will lead complaints and critical deviations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions and follow company standards. You will own and/or support complaint trending activities including, but not limited to annual product quality reviews and quarterly trending reports. You will collaborate with departments (e.g. Affiliates, Manufacturing sites, external quality, quality control etc.) to establish appropriate, efficient, and timely investigation plans. You will notify senior management of potential quality or regulatory issues that may impact product quality or regulatory compliance. You will communicate new and updated regulatory requirements and evaluate systems in place. You will support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures. You will solve complex problems; both inside and outside of the quality organization You will work independently within standard guidelines, policies and health authority regulations and mentor others You will serve as primary consultant to senior management and internal/external spokesperson for the organization Who you are: You have a BS/MS Master's degree (Life Sciences or Engineering, preferred) and significant relevant bio/pharmaceutical experience in a Good Manufacturing Practices environment (Drug Product and/or Device preferred) You have 4+ years (level II) and 8+ years (level III) of industry experience preferably in a biologics manufacturing environment You are able to deliver business outcomes in support of departmental and site objectives. You are able to work in an agile organization, flow to work and apply skills where resources are needed You have sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to commercial manufacturing. You have excellent communication skills and are able to gown into production space The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $77,000 - $143,000 (for level II) and $94,000 - $174,000 (for level III). Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Please note this role is eligible for relocation benefits. Link to Roche/Genentech Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

Posted 1 week ago

ALS Global logo
ALS GlobalTorrance, California
At ALS, we encourage you to dream big. When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future. Position Title: Document Control Specialist 1 Generic Position Code/Title: SCI25/Quality Coordinator Business Stream: Pharmaceutical and Beauty and Personal Care Location: Torrance, CA USA Line Manager: Quality Assurance Director Direct Reports: N/A FLSA Status: Non-Exempt Primary Objective: The Document Control Specialist 1 will be responsible for administering routine QA activities directly related to data entry, issuing, editing, filing, and archiving of quality systems data and documentation. Position Duties and Scope: The Document Control Specialist 1 has the following duties: Maintain and administer controlled document system, including standard operating procedures, test methods, forms, and supporting documents. Assist in editing of controlled documents, including design of forms. Issue controlled copies of Forms to individual departments and administer tracking system for satellite document sets. Maintain document revision activity and files of completed DCR’S (document change record), and other quality system documentation, as applicable. Generate, issue, and archive laboratory notebooks. Proactively manage the document lifecycle process. Maintain archives of completed laboratory notebooks, validation projects, and master documents. Administer the collaboration with external archival storage facilities, as necessary. This includes verification of items for archival, scheduling of archive pick-up and retrievals, and confirmation of destruction activities in compliance with retention policy. Maintain training record files for employees, as necessary. Act as Document Control Administrator for Electronic Quality Management System. Train employees on document control processes to ensure ongoing compliance. Support Human Resources with New Hire documentation. Creates set-up of new employees and termed employee de-activation of in the Electronic Quality Management System. Meeting agenda preparation and minute recording, as necessary. Retrieve documentation for client and external audits. Maintain the documents needed for the Audit Ready box. Support supply ordering for the QA department. Maintain an understanding of and ensures compliance to Quality System including the manual, system procedures (cGMPs and cGDPs) and procedures as applicable to ISO 9001and ISO 17025 Maintain a clean and organized workspace. Exercise Laboratory safety practices. Other duties as required. Position Requirements/ Essential Criteria: Minimum: Associate’s degree or equivalent. Preferred: Bachelor’s degree in a related field such as: Business Administration Quality Assurance / Quality Management Life Sciences or similar 2–4 years of experience in document control, records management, or quality systems (e.g., in manufacturing, pharma, biotech, or engineering environments). Experience with Quality Management Systems (QMS) or Electronic Document Management Systems (EDMS) (e.g., Master Control, CPro, Track Wise, eQMS). Familiarity with ISO 9001, ISO 17025, cGMP, or FDA 21 CFR Part 11 requirements, depending on industry. Core Competencies: Proficient in: Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe Acrobat.) Electronic document control systems (EDMS/eQMS) Document lifecycle management (creation, revision, approval, archival) Understanding of: Change control and document numbering systems Version control and document traceability Controlled copy issuance and retrieval processes Proficient verbal and written communication skills. Excellent organizational skills and attention to detail. Remains flexible, professional, and patient when dealing with changing priorities and assignments. Comprehension and awareness of the importance of achieving regulatory compliance. Key Competencies: Knowledge of document workflows and approval processes Ability to audit documentation for accuracy and compliance Competence in training or supporting users in document control processes Understanding of retention policies and records archiving Occupational Health & Safety Responsibilities: Follow all company operating procedures, standards, policies, and training to ensure the safe and efficient operation of the site. Play an active role in the ALS safety program by correcting or reporting unsafe acts and conditions that are observed during the day-to-day operations to create a zero-injury work environment. Participate in and support HSE initiatives, as required by ALS leadership. Understand and use HSE precautions (such as but not limited to fume hoods and PPE) while working with chemicals and samples of unknown hazards. Ensure the health and safety of staff, contractors, and/or visitors by providing appropriate leadership, due diligence, resources, training, and enforcement for all individuals onsite. Monitor and enforce the health, safety and environment policies, procedures and ensure compliance with the relevant regulations. Actively promote awareness of these policies, procedures, and regulations amongst company personnel. Actively support and participate in all OHS initiatives. Lead by example. Report all personal injuries and incidents and assist with investigations as per company policy. Ensure the company sites adhere to all environmental requirements as determined by government legislation, regulation, and company policy. Quality Responsibilities: Ensure business is conducted in accordance with Core Values: Safe Resilient Curious Committed Caring Honest Ensure Quality Systems are adhered to in performance, review, and reporting of laboratory duties and communicate all quality issues. Support Quality Department and Continuous Improvement Processes. Employees commit to improving the ALS experience through effective communication. Take appropriate steps to foreshadow potential risks and establish contingency plans. Ensure all statutory management and reporting requirements are met. Ensure compliance and continuous improvement of the Quality Management System. Other Requirements: Working at a computer, up to eight (8) hours per day. Sitting and/or standing for extended periods of time, up to eight (8) hours per business day. Must be able to sit, stand, bend, push, pull, stoop and crouch up to 50% of the time while performing the duties of this position. Position may require the lifting of items up to 25 lb in weight. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Working at ALS The ALS team is a diverse and dedicated community united by our passion to make a difference in the world. Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence. At ALS, you’ll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us. We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities. Everyone Matters ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued. Qualified candidates will be considered without regard to race, colour, religion, national origin, military or veteran status, gender, age, disabilities, sexual orientation, gender identity, pregnancy and pregnancy-related conditions, genetic information and any other characteristics protected by the law. We invite resumes from all interested parties, including women, members of minority groups, and persons living with disabilities. ALS also welcomes applications from people with all levels of ability. Accommodation is available on request for candidates taking part in all aspects of the selection process. Eligibility To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa. How to apply Please apply on-line and provide a cover letter and CV that best demonstrate your motivation and ability to meet the requirements of this role.

Posted 30+ days ago

PCI Pharma Services logo
PCI Pharma ServicesMadison, Wisconsin
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. What You’ll Do As a Training Specialist , you’ll play a critical role in strengthening PCI’s training program across aseptic and non-aseptic manufacturing operations. You’ll ensure our teams have the knowledge, skills, and confidence to perform at their best. In this role, you will: Deliver On-the-Job Training (OJT) to operators and functional teams, mentoring them toward confident, compliant performance. Develop and maintain engaging training materials—checklists, job aids, qualifications, e-learning modules, and more. Facilitate instructor-led training on GMP, technical skills, and functional topics. Partner with cross-functional leaders to assess training needs and design effective learning solutions. Track qualifications, generate training reports, and ensure compliance through our eQMS (Master Control). Keep training programs up to date with process improvements, new SOPs, and quality events. What We’re Looking For We’re seeking a collaborative trainer and GMP professional with a passion for quality and a drive to support others in their development. Skills & Experience: 5–10 years in a GMP-regulated pharmaceutical, biotech, or medical device environment (aseptic manufacturing preferred). Hands-on knowledge of aseptic practices—gowning, formulation, fill/finish. Experience creating and delivering training materials, including OJT and e-learning. Strong communication skills—you can present confidently to individuals or large groups. Proficiency in MS Office and familiarity with eQMS/LMS platforms (Master Control experience a plus). A track record of working effectively in cross-functional teams and managing multiple priorities. Education: Bachelor’s degree in science, adult education, pharmaceutical processing, or related field (or equivalent industry experience). #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Posted 2 days ago

Ketryx logo
KetryxBoston, Massachusetts

$130,000 - $150,000 / year

Job Title: AI Native QA/RA Lead Employment Status: Full-time Office Hours: Monday - Friday; hybrid schedule Location: Boston, Massachusetts (hybrid), USA (remote), OR Toronto (remote) Compensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level) As a Ketryx AI Native QA/RA Lead, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world’s most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform. Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices. This position will be based in our Boston, Massachusetts office, preference for candidates within the Boston area to work a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Remote and Toronto (remote) candidates may be considered, as well. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time. About You: You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining. Responsibilities: Lead Quality Management System (QMS) setup and deployment for medical device clients Own and manage QMS templates and regulatory compliance frameworks Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards Scale operations to support high-growth clients Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance Shape the future of regulatory affairs through innovative product development Work independently on complex quality assurance projects requiring minimal oversight Ensure customer success across the entire customer engagement lifecycle Required Skills: 4-8 years of experience in quality systems management, management representative or senior specialist role Familiar with eQMS implementation, validation and implementation. Deep expertise in Quality Management System setup, sub-systems, and implementation Strong knowledge of ISO 13485 and Global QMS requirements Expertise in AI, Digital, and Cyber Compliance Deep understanding of medical device cybersecurity Experience as quality management representative in regulated environments Experience with regulatory and Notified Body submission requirements Background in medical device industry quality systems Ability to work independently and own complex regulatory projects Proven track record in consulting or client-facing roles Preferred Skills: Experience at large medical device companies (Stryker, Medtronic, Boston Scientific) Background with consulting firms specializing in QMS setup Startup experience (Series A/B) with QMS implementation Specializations in cybersecurity, usability, or computer software validation Experience scaling quality operations in high-growth environments Knowledge of AI applications in regulatory affairs Submission experience Keywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, Stryker, Medtronic, Boston Scientific, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry What We Offer Competitive compensation Generous stock options possible Work in an exciting field with a positive impact on the world Opportunity to learn and grow as part of a global team Generous PTO for full-time Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster. Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!

Posted 3 weeks ago

Jahnel Group logo
Jahnel GroupSchenectady, New York
LTI (Logic Technology, Inc.) the "Pro People" company is a privately held technology solutions provider that offers best in class services to local, national and global organizations. Now after three decades, these initials have come to represent more than just our company name. They’ve also come to represent our hard earned reputation for Leadership, Technology and Integrity. At LTI, we believe confident, motivated employees produce superior work, ensuring our existing client relationships continue to run smoothly. LTI actively creates an environment where great professionals want to be. We offer great benefits, interesting work and personal development opportunities. Overview We are looking for a QA Automation Engineer experienced in Java-based automation frameworks to design, develop, and maintain automated testing solutions. This role centers around building scalable test frameworks using Selenium and Cucumber, integrating them into Jenkins pipelines for continuous delivery. Responsibilities Develop and maintain automated test scripts primarily in Java, with some supporting functions in JavaScript. Utilize Selenium WebDriver to automate browser actions and Selenium Hub + Grid for distributed test execution on remote servers. Configure and integrate test automation within Jenkins, leveraging JNLP agents for remote execution. Create BDD test scenarios using Cucumber and Gherkin syntax to drive test coverage and clarity. Implement and manage JDBC connections for validating data directly against the database. Troubleshoot and optimize test suites to improve performance, stability, and reliability. Collaborate with developers, QA, and DevOps teams to ensure smooth CI/CD integration and consistent test quality. Participate in code reviews, framework enhancements, and continuous improvement of QA processes. Required Skills & Qualifications 3–6 years of experience in test automation or software QA roles. Strong proficiency in Java; working knowledge of JavaScript. Hands-on experience with Selenium WebDriver, Selenium Hub/Grid, and Cucumber (BDD) frameworks. Solid understanding of Jenkins pipelines and JNLP protocol for distributed builds. Experience with SQL and JDBC for database-driven testing. Familiarity with test frameworks such as JUnit or TestNG. Excellent debugging, analytical, and communication skills. Preferred Skills Experience with version control systems (e.g., Git). Familiarity with API testing tools (e.g., RestAssured, Postman). Understanding of cross-browser testing and environment management. Where We're Looking For It Schenectady, New York 100% Remote for the right candidate Other Information The work hours will be approximately 8:00 am to 5:00 pm EST, depending on workload, with the occasional late night when a tight deadline calls for it. We work for security-conscious clients, thus background checks will be required. Salary dependent upon experience.

Posted 1 week ago

Standard Bots logo
Standard BotsGlen Cove, New York

$140,000 - $180,000 / year

About Standard Bots Standard Bot’s mission is to significantly lower the barrier to entry to real-world automation, bringing the power of bits to the world of atoms and unlocking productivity for entire new industries and users.We combine advanced engineering, intelligent automation, and world-class manufacturing to create products that redefine what's possible.We are seeking a detail-oriented and experienced Hardware QA Manager to lead our Quality Assurance efforts across all hardware platforms in our fast-paced robotics manufacturing environment. Note: This role will be required to come into our Glen Cove robotics factory 5 days/week We are unable to offer visa sponsorship at this time What you'll do The Hardware QA Manager will be responsible for developing, implementing, and maintaining comprehensive quality assurance systems and protocols for robotic hardware. This individual will lead a team of QA engineers and technicians to ensure all hardware components meet strict reliability, safety, and performance standards before and after release. This role requires close collaboration with cross-functional teams including Engineering, Manufacturing, Supply Chain, and Product Development. Responsibilities Lead the hardware QA team in planning, implementing, and executing test strategies and protocols for robotic hardware systems (mechanical, electrical, and embedded components) Work with the manufacturing and assembly teams to drive improvements in quality and efficiency Define and maintain hardware quality standards and ensure compliance with industry regulations (e.g., ISO, ANSI, IPC, RoHS, etc.) Drive root cause analysis (RCA) and corrective/preventive action (CAPA) for hardware defects or failures Coordinate with Manufacturing and Supply Chain to ensure quality standards are upheld throughout production and vendor operations Develop automated and manual test plans for validation and verification (V&V) of hardware systems at component and system level Participate in design reviews to ensure DFM (Design for Manufacturability) and DFT (Design for Testability) are considered Manage incoming inspection protocols, First Article Inspections (FAIs), and supplier audits Lead internal and external audits and represent the QA function during regulatory inspections or customer visits Build and mentor a high-performing QA team, promoting a culture of quality, accountability, and continuous improvement Skills you'll bring Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Mechatronics, or a related technical field 7+ years of experience in hardware quality assurance, preferably in a robotics, automotive, or high-tech manufacturing environment 3+ years of experience in a management or leadership role within QA Strong understanding of hardware development lifecycles, including prototyping, NPI, production ramp, and sustaining Proficient with quality tools and methodologies such as FMEA, Six Sigma, SPC, 8D, etc Experience with test equipment and diagnostic tools used for electronics, firmware, and electromechanical systems Familiarity with manufacturing processes such as SMT, injection molding, CNC, etc Strong analytical, problem-solving, and communication skills Ability to work in a fast-paced, multidisciplinary team environment Preferred Qualifications Experience with robotics systems, motion control, or autonomous platforms. Bonus for software/firmware experience Experience creating a Quality Management System from scratch (particularly to QA/QC and test generation) Experience working with global suppliers and contract manufacturers Certifications such as ASQ CQE, Six Sigma Black Belt, or ISO 9001 Lead Auditor Compensation and Benefits The salary range for this role is $140,000 to $180,000. We are open to a variety of seniority levels for this role and will build compensation packages that are commensurate with seniority and skill level. Base salary is just one part of the overall compensation at Standard Bots. All Full-Time Employees are eligible for Employee Stock Options. We also offer a package of benefits including paid time off, medical/dental/vision insurance, life insurance, disability insurance, and 401(k) to regular full-time employees.

Posted 30+ days ago

KBI Biopharma logo
KBI BiopharmaDurham, North Carolina
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The Quality Systems team is responsible for establishing and continuously improving the Quality Management System (QMS) that supports the site and Global Compliance activities ensuring systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture and holding of materials for our company. The Quality Systems departments goal is support of the site teams to achieve a culture of ongoing regulatory readiness and sustained compliance that delivers safe, pure and effect materials to our clinical and commercial clients. The Senior Quality Assurance Specialist – Client Support is a key Individual Contributor and client projects leader on the Quality Systems team, serving as the Quality-to-Quality client liaison. The incumbent collaborates closely with counterparts throughout the Quality team, supporting processes required to ensure compliance with internal quality documents, regulatory requirements, and cGMP for early and late phase clinical and commercial manufacturing. The incumbent will be responsible for providing support for such activities as product release, deviation, complaint and supplier investigation and closure and facilitating associated collaborations. Additionally, the incumbent will support the compilation, analyzing and reporting of associated metrics. The role requires routine interactions with all functions supporting the external network, including interaction with functions across the company’s global network. This role is an onsite hybrid role, working a schedule Monday through Friday between the hours of 8:00 am – 5:00 pm. Responsibilities: Serves as QA facilitator for the Quality aspect of client projects: accountable as the Quality lead, actions coordinator and delegate for the site client project team, joint QA and related meetings. Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline. Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed. Interfaces with the PMO team to ensure Quality topics are addressed. Supports Batch disposition, fully executing the disposition process as needed. Supports audit / inspection readiness of the site. Participates in regulatory and other quality/compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned. Works with Global Compliance to support Client Audits Supports Deviation Management activities by participating in investigational meetings, activities, writing and approving investigation as needed. Assists with compiling, reviewing/ approving Quality Systems and Compliance documentation and reports. Demonstrates knowledge of Quality Systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles. Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, audit support. Demonstrated ability to keep Project Leads, such as PMs and team members, informed of the status of assigned work. Ability to determine where escalation is necessary. Capability of being flexible as required tasks change and maintain productivity. Requirements: BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 5-7 years of relevant experience as described below. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements. Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role Ability to communicate in customer-facing forums to progress issues and obtain positive results. Ability to work professionally with others and facilitate positive interdepartmental interactions with a diverse group of people. Includes ability to navigate conflict to achieve deliverables and drive to targeted outcomes, as well as to resolve differing perspectives with effective negotiation. Listens and is attentive to others’ ideas and contributions. Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently. Voluntarily communicates needs and suggestions clearly and effectively. Demonstrated strong attention to detail and effective investigation, problem solving, and organizational skills. Ability to properly prioritize tasks and manage time effectively. Proactive approach to drive tasks to completion. Excellent written and verbal communication skills. Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc. Ability to compile and analyze data and information from multiple sources Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365). Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS p Ability to sit for extended periods of time. Ability to work on site in a manufacturing environment periodically. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

C logo
Craft & Technical SolutionsSan Diego, California

$24+ / hour

Description Craft and Technical Solutions is an established Marine and Industrial Staffing Company with offices all over the country. We partner with businesses as well as jobseekers to place individuals into positions efficiently. We are currently in need of QA/QC Inspectors to join our team in San Diego, CA! Pay Rate: $24/hour Job Details: Perform basic inspection of shipbuilding and ship repair work in accordance with established policies to ensure compliance with technical requirements Performs other Quality Assurance tasks as assigned by supervisor/manager Ensure correct materials and proper fabrication and installation procedures are utilized during production processes Evaluate results from tests and inspections to determine acceptability with assistance as needed Basic understanding and ability to research technical documents including engineering drawings, specifications, standards, test procedures, work instructions, NAVSEA Standard Items, and contract requirements Basic understanding of the usage of calibrated equipment and ability to validate calibration of equipment, gauges, and tools used in production and inspection in accordance with established policies Basic ability to recognize and document nonconformance’s per company policy Basic understanding of root cause analysis, corrective action, and preventative action practices Ability to learn and perform process audits and surveillances Drafts, reviews, and/or submits QA reports and technical documents Actively participates in implementing and monitoring continuous improvement initiatives to improve safety, improve quality, reduce cycle time, and reduce costs Brings complex issues to the attention of Supervision Requirements High School education or equivalent; Additional technical education or college education a plus Zero to four (0 – 4) years of Quality Assurance or related experience Knowledge of shipbuilding and repair operations a plus Ability to develop technical knowledge of ship construction and repair processes including welding, structural, machinery, electrical piping, ventilation, flushing and develop familiarity with various measuring instruments related to inspections. Computer literate; knowledge of Microsoft Word, Excel, Outlook, PowerPoint, and IFS Quality Modules a plus Good written and verbal communication skills, integrity, presentation skills, problem solving skills Positive attitude and determination to help others required Able to learn to read and understand blueprints, standard/specifications, regulatory body requirements, and ship specifications Must be a team player Benefits CTS, LLC offers a comprehensive benefit packet to eligible employees. Eligible employees may enroll in: Health Dental Vision Voluntary Life/Voluntary AD&D Short-Term Disability Long-Term Disability Hospital Indemnity Accident Critical Illness 401k Safety and responsible work practices are of paramount importance at CTS and are woven into the fabric of everything we do. We are committed to employee safety & development, the protection of the environment and the communities where we operate. We are ready to be a partner in your career success! Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform essential job functions. Craft and Technical Solutions, LLC has a consistent policy that requires an online application to be completed before we can further consider you as an applicant for this position. CTS is an EOE AA M/F/Vet/Disability

Posted 30+ days ago

American Regent logo
American RegentShirley, New York

$79,900 - $85,000 / year

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. Ensure deviation timelines are maintained through inter-department communication. Facilitate and lead assigned investigations involving multiple investigation areas. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. Under supervision assist with documentation for the closure of complaint investigations. Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audits and inspections as required. Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current in ISO train. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelor’s degree in a science or engineering field. ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. Ability to apply critical thinking to scientific problems and demonstrated knowledge. Ability to apply statistical quality management concepts. PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal ( eeoc.gov ) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com .

Posted 3 weeks ago

E logo
Employment at ASASchaumburg, Illinois

$16 - $18 / hour

Summer Intern – Information Technology (IT / QA)Schaumburg, IL – Flexible Hybrid Schedule The American Society of Anesthesiologists (ASA) is currently hiring a Summer Intern for Information Technology (IT) located in our corporate headquarters in Schaumburg, IL. This part-time, seasonal position will offer challenging work/project(s) within an exciting industry. The Summer Intern will have the opportunity to work alongside experienced Association professionals in a flexible, innovative, mission-driven, and member-centric environment. Internship Responsibilities: This position would assist the IT Quality Assurance (QA) team with unique and critical projects. Primary responsibilities include: The intern will work and report to the QA manager and QA Analyst to deliver comprehensive systems, application and web testing plans related to sprint releases or operational enhancements/projects. This individual will use appropriate methods (functional, regression, performance etc.) to drive the end-to-end testing and issue resolution process. This individual will be involved in writing test plans, test cases and scripts along with tracking / documenting defects and fixes. Internship Qualifications: Education related to Computer Science or Information Systems. Proficient in Microsoft Office applications including Excel, Word and Teams. Familiarity with web/mobile platforms, ASP.net web applications MS SQL Database experience (backend), or development methodologies required. Basic to intermediate MS SQL experience a plus. Understanding of programming languages such as C#, Java and algorithms helpful. Ability to analyze and solve problems effectively. Internship Details: Paid internship. 10-12-week commitment (during summer). Interns will work approximately 25-29 hours per week. Interns will be closely managed/mentored by their hiring manager. Interns will receive feedback regarding their work and performance. Internship Eligibility: Students must be enrolled in a college/university. Students must interview with Human Resources and the Manager/Director who will be responsible for overseeing the work. Students must intern in an area which is related to their academic major and degree. About ASA: The American Society of Anesthesiologists (ASA) team provides education, resources, and advocacy to help our members improve the experience and safety of patients in their care. You can be a part of this important work—join more than 160 change-makers, collaborators, and advocates as we continually work towards excellence. We live our core values of collaboration, dedication, commitment, and improvement every day. And we know that diversity in the way we look, think, learn, and live makes everything ASA does better. Our policies, culture, and people strengthen this commitment every day. As a result, ASA has been named one of the Best and Brightest Companies to Work For in Chicago and the Nation ® for the past nine years. Position Compensation: This position is an hourly or exempt/salaried position. The pay for this position is $16.00 per hour (undergraduate) and $18.00 per hour (graduate program). This position is not eligible for benefits or a yearly bonus/incentive.

Posted 3 weeks ago

Thermo Fisher Scientific logo
Thermo Fisher ScientificGreenville, North Carolina
Work Schedule First Shift (Days) Environmental Conditions Office Job Description Location/Division Specific Information The Drug Product Division (DPD) is one of the three divisions that make up the Pharma Services Group (PSG) in the Biopharma Services (BPS) Sector at Thermo Fisher. We have more than 9,000 colleagues across 13 sites who specialize in taking sterile injectable, oral solid dose and softgel drug products from development to commercialization. As the Contract Development Manufacturing Organization (CDMO) market leader, we have built a reputation for scientific and technical excellence, and DPD has benefitted from capital investments in capacity expansion and new capabilities to ensure our long-term growth as we continue to meet our customers' evolving needs. *Relocation assistance is NOT provided. *Must be legally authorized to work in the United States without sponsorship . *Must be able to pass a comprehensive background check, which includes a drug screening. How Will You Make an Impact The Senior Quality Specialist – Project Lead at Thermo Fisher Scientific plays a crucial role in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations. This position is responsible for maintaining full company compliance to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction. A Day in the Life Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations. Oversees the quality of methods, processes, materials, and products by coordinating and reviewing group operations, providing staff training, and assessing/improving systems and processes. Responsible for reviewing and approving procedures, training documents, forms, deviation, and change control of moderate to high complexity. Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety, and business risks. Act as a technical resource for system support and new product introduction by interpreting regulatory requirements and establishing systems. Makes decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering the level of risks related to compliance and product quality. Education Bachelor degree required, preferably in technology, engineering, scientific field or related area required. Experience 7+ years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required. Knowledge, Skills, Abilities Project management expertise Strong knowledge of regulatory requirements and quality standards Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing. Professional certifications (e.g., CQA) and training in Six Sigma are beneficial. Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence is essential. Ability to work independently and to remain firm in complex situations is required in this fast-paced environment. Physical Requirements/ Work Environment Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. What We Offer We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation Competitive Hourly Pay Rate Additional shift differential for 2nd shift and 3rd shift positions Annual performance-based bonus Annual merit performance-based increase Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays 401K Tuition Reimbursement Employee Referral Bonus Career Advancement Opportunities Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today: http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Posted 30+ days ago

Decima International logo
Decima InternationalLubbock, Texas
Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula: Approach each client engagement as a partnership , create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards. If you are interested in a long and rewarding career working with high-profile clients on some of the most challenging projects in the world, then Decima is where you belong. At Decima, you will be able to explore incredible growth and professional development opportunities. We are looking for a driven and capable Mechanical QA Inspector to support us with the development of multiple hyperscale data center projects for one of our top technology clients. This is a client-facing role that requires strong interpersonal, communication and organizational skills, ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently. A strong background in data center development, design, engineering, controls, and operations requirements is a big plus. You will play an integral role in ensuring the development and implementation of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction audits and commissioning services of the project. The Mechanical QA Inspector is accountable for the quality of work performed, compliance with building codes, safety regulations, as well as meeting the project’s contractual requirements set forth by the client. We are looking to bring in dedicated individuals with a passion for innovation and talent for multitasking in a fast-paced environment. We will help you grow, pursue, and fulfill what inspires you so we can make big impacts on the world, together. RESPONSIBILITIES Understand the project scope and requirements. Ensure compliance with quality standards, building codes, safety regulations, and environmental guidelines. Review and verify material submittals for A/E and Client approval. Confirm delivered materials match approved submittals. Manage and review submittals, RFI logs, maintenance logs, and other project documents promptly. Update QC punch lists and coordinate with general contractors (GC) and subcontractors for completion. Conduct internal quality audits and site inspections. Adhere to Quality, Health, Safety, & Environment (HSE) standards. Provide technical support to address operational challenges and client concerns. Plan and inspect Definable Features of Work (DFWs). Develop and implement Audit and Test Plans for quality inspections and testing. Maintain and update Quality manuals, checklists, and forms. Collaborate with third-party QA/QC firms as needed. Participate in Quality Management System (QMS) audits. Build relationships with project partners, consulting engineering firms, public agencies, and clients. Ensure document control compliance and maintain project submittal logs and quality control reports. Verify and document material compliance with approved submittals. Compile and forward project closeout documents, including O&M manuals, as-builts, and warranties. Investigate and address non-conformance issues promptly. Ensure calibration of inspection, measurement, and test equipment. Liaise with the General Contractor, Client, and Project Management team to resolve quality issues. Prepare presentations on progress, findings, and recommendations for management. Review subcontractors’ submittals for compliance. Coordinate and monitor subcontractors, suppliers, direct labor, and materials. Collaborate with public utility suppliers for final service connections. Coordinate activities of inspection agencies. Achieve required MEPS and electromechanical inspections. Assist in preparing periodic QA/inspection progress reports. Review and approve subcontractor work percentages. Oversee commissioning processes. Manage the MEP project closeout to ensure all requirements are met. QUALIFICATIONS Required Qualifications : 15+ years of construction and quality management experience. Bachelor’s degree in mechanical, electrical engineering, or a related field. Experience with managing field engineering, inspection, and NDE related to all QA/QC functions. Proficient with reading, understanding, and interpreting plans, specifications, drawings, contracts, and other documents pertaining to MEP aspects of projects. Ability to develop and manage non-conformance, defects, and reporting programs, including root cause analysis. Ability to ensure correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded. Ability to work in high-production environments and respond quickly and effectively under pressure and deadlines while maintaining a professional demeanor. Technical knowledge of materials and construction concepts. Experience working as a Mechanical Quality Supervisor for large commercial, industrial, or mission-critical facilities construction projects. An excellent understanding of construction Quality Management Systems (QMS). Familiarity with punch list procedures and project closeout processes. Strong attention to detail and excellent analytical skills. Strong knowledge of high, medium, and low-voltage systems, HVAC, control systems, commissioning, LEED/Green building projects, and general ground-up construction projects as applicable to MEPS. Preferred Qualifications: Project Management Professional (PMP) certification. Construction Quality Manager Certification (CCQM) US Army Corps of Engineers (USACE) Certified Quality Auditor (CQA) Member of the American Society for Quality Six Sigma Certifications ISO 9001 Green Business Certification (LEED) Strong background in data center development and construction POSITION DETAILS: Primary Location (On-site): Lubbock, Texas Position: Mechanical QA Inspector Position Classification: Salary-based full-time hours Current US work permit required. This position does not offer sponsorship for employment (e.g., H-1B visa sponsorship or transfer not offered) PRODUCTIVITY TOOLS: ​ Microsoft Office Microsoft 365 CxAlloy Decima International is an Equal Opportunity Employer who is committed to the safety and wellbeing of all. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. At Decima International, we offer a competitive salary package, including paid time off and performance-based bonuses. We also provide excellent medical, vision and dental insurance for our employees.

Posted 30+ days ago

KBI Biopharma logo
KBI BiopharmaDurham, North Carolina
JOB SUMMARY This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- process, and stability test data. This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department. JOB RESPONSIBILITIES: Performs compliance review on the following records: release, in-process, and stability data. Responsible for the review and approval of method qualifications and validations Responsible for the review and approval of deviations and laboratory investigations. MINIMUM REQUIREMENTS: BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Be able to sit for long periods of time. Ability to lift 20 pounds. Ability to use w ord processing, database, spreadsheets, power point, internet, e-mail, calendar, c omputer, telephone KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

F logo
Fastbreak AICharlotte, North Carolina
Description The Role We're seeking a QA Engineer who brings both creative problem-solving and rock-solid testing fundamentals to our team. You'll be the detective who uncovers edge cases others miss, the strategist who designs comprehensive test plans, and the technician who builds elegant automation frameworks. This role blends manual exploratory testing with modern automation practices, and you'll have the opportunity to pioneer AI-assisted testing approaches as the field evolves. You'll work closely with product and development teams to ensure our web and mobile applications deliver exceptional user experiences. This is a hands-on role for a self-starter who thrives in fast-paced environments and can balance multiple priorities. What You'll Do Uncover Hidden Issues Through Creative Testing – Apply exploratory testing techniques and user-centric thinking to find bugs that automated tests might miss; challenge assumptions and discover edge cases Embrace AI-Powered Testing – Learn and implement emerging AI-assisted testing tools and frameworks to optimize testing efficiency and effectiveness Build Robust Test Automation – Design, develop, and maintain automated test suites for web (Next.js, Node.js) and mobile applications using modern frameworks Master the Fundamentals – Create comprehensive test plans, write clear test cases, execute thorough manual testing when needed, and ensure proper test coverage across features Own Quality End-to-End – Take ownership of the testing process, identify gaps, and proactively propose improvements to testing strategies and methodologies Collaborate Cross-Functionally – Partner with developers, product managers, and stakeholders to define testing strategies, reproduce issues, and advocate for quality Manage Testing Operations – Track defects in JIRA, maintain test documentation, use Git for version control, and contribute to continuous improvement of QA processes Requirements Required 3+ years of QA engineering experience , preferably in a SaaS or technology company Strong testing fundamentals – deep understanding of test methodologies, test case design, boundary testing, regression testing, and quality assurance principles Creative bug-finding skills – demonstrated ability to think outside the box, anticipate user behavior, and discover non-obvious issues Hands-on automation experience with web and mobile applications (experience with tools like Selenium, Appium, Cypress, Playwright, or similar) Manual testing expertise – comfort with exploratory testing and knowing when manual testing is the right approach Technical aptitude – ability to read code, understand technical architecture, and work effectively with development teams Self-starter mindset – proactive, autonomous, and able to manage multiple projects simultaneously Curiosity about AI tools – eagerness to explore and adopt AI-assisted testing frameworks as they emerge Proficiency with JIRA for bug tracking and test case management Preferred BA/BS degree in Computer Science, Engineering, or related field Experience with JavaScript/TypeScript for test automation Knowledge of CI/CD pipelines and integrating automated tests into development workflows Familiarity with performance and load testing tools and methodologies Experience with API testing and backend validation Exposure to AI-powered testing tools or machine learning concepts in QA Benefits https://www.fastbreak.ai/careers Competitive salary and comprehensive benefits. Company stock options. Health, dental, and vision insurance to keep you covered. A 401(k) plan with employer contributions to invest in your future. The opportunity to shape the future of a rapidly growing and well-funded company and make your mark. More about careers at Fastbreak AI . If this sounds like you, please apply! This is an immediate opening. NOTE: Applicants must be legally authorized to work in the USA. We are unable to sponsor or take over sponsorship of an employment visa at this time. We are an equal-opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Posted 1 week ago

QGenda logo
QGendaAtlanta, Georgia
Who We Are QGenda is redefining healthcare workforce management everywhere care is delivered. We're on a mission to empower the healthcare industry to better onboarding, deploy, and manage their workforce. Over 4,500 healthcare organizations have trusted us to help them make strategic workforce decisions through our unified software platform. With more than 700 employees across the US, we are united in our vision and culture to make a difference for our customers, while enjoying the day-to-day. At QGenda, we value our employees and their contributions toward the success of the business. We strive to create a dynamic work environment that fosters growth, innovation, and collaboration, where employees can be proud of the work they do and the impact it has on the healthcare industry. QGenda is headquartered in Atlanta. To learn more about QGenda, visit us at qgenda.com or follow us on Instagram or LinkedIn . About Your Role In your role as a QA Engineer, you will be an integral part of ensuring the quality of our products by building test plans and executing test cases for various features and functionality on our web and mobile applications. You will work closely with Developers and fellow QA Engineers on a scrum team focused on delivering software that meets the needs of our customers. We value collaborative discussions and creative ideas on how to further enhance our testing strategies and processes. Our teams solve challenging problems ranging from automating complex schedules to developing optimized user interfaces for visualizing schedules. If tackling these kinds of challenges sounds interesting, we'd love to talk to you! How You’ll Make an Impact Partner with teammates and developers to assist in advancing our world-class software Assist in building product test strategies, write and execute test plans, file bugs Effectively communicate with the team about issues, risk, and product quality Develop and execute regression tests on every release, reporting findings back to the team Support the target of inbound bug reports and reproduce issues alongside the team Bring new and innovative ideas to help advance our test methodology and approach Who You Are Strong critical thinking and problem solving skills Strong ability to self organize and prioritize tasks Strong technical writing skills Ability to effectively communicate with partners Hands-on experience testing a SaaS web application(s) Knowledge of best practices and standards for web applications Experience You Bring 1-2 years experience as a QA engineer within an agile development team Hands-on experience testing a SaaS web application(s) Knowledge of best practices and standards for web applications Experience testing iOS and Android applications Experience with agile software management tools (JIRA, VersionOne, etc.) #LI-Hybrid Applicants for this position must be authorized to work for any employer in the United States(U.S.), including being located in the US. We are unable to sponsor, take over sponsorship of, or hire candidates with an employment visa at this time. What’s In It For You We offer a comprehensive total rewards package to support our full-time employees and their family’s day-to-day needs, well-being and major life events, which includes: Fully company-paid options for medical (both in-person and virtual), dental and vision insurance Generous paid time off (PTO) policy to enjoy periods of uninterrupted rest and relaxation for a healthy work/life balance Paid parental leave for birth, adoption or permanent placement 401(k) with company match Options to work in a hybrid-working model or remotely from home, depending on the position Annual Costco membership, cell phone stipend, commuter benefits, in-office perks and more QGenda delivers technology solutions to improve how healthcare is delivered and increase access - for everyone. We can only succeed by bringing together diverse minds, thoughts, ideas and team members to create better solutions for our customers and make us a better company as a whole. We are committed to creating a culture of embracing diversity, inclusion and equity for all. QGenda is an Equal Employment Opportunity employer and makes all employment decisions without regard to race, color, religion, creed, gender, sex (including pregnancy), sexual orientation, gender identity or expression, natural origin, ancestry, age, marital status, disability or genetic information, military status, status as a disabled or protected veteran or any other protected status under applicable law. If you require accommodations or assistance to complete the online application process, please contact recruiting@qgenda.com and identify the type of accommodation or assistance you are requesting. Do not include any medical or health information in this email. We will respond to your email promptly.

Posted 1 week ago

Aechelon Technology logo
Aechelon TechnologyOverland Park, Kansas
Aechelon Technology, Inc. is a leading producer of 3D simulator content, including Geospecific visual/sensor databases and realistic 3D models. We seek people who share our passion for real-time computer graphics and commitment to our mission of helping make our Nation’s pilots safer. We will give you a chance to work with some of the most talented people in the graphics industry. Our Software team is looking for a QA Test Engineer to help us in our mission. The QA Test Engineer role supports our Software, Database, and Systems Engineering teams by testing our proprietary Image Generator (pc-Nova) by creating automated tests via scripts as well as maintaining our proprietary test system and test lab system at location. Our test system is designed to ensure that pc-Nova performs at high framerates on high-end hardware such as projectors, MR headsets, etc. This position requires Python programming expertise in order to maintain our current setup as well as build new test features as needed. This position requires 5 days per week in-office at the company’s Kansas location: this is not a remote work position. Note that this requirement can change based on the applicant's familiarity with our test system infrastructure. United States citizenship required due to restrictions on access to certain data. Responsibilities will include, but not be limited to the following: Maintain the QA test lab to ensure all test system are operational to support the testing by Kansas-based engineers Work with platform team to either upgrade or order new test system (HW, FW & SW) as needed by Kansas-based engineers Work with Kansas-based engineers to reproduce issues in the lab Maintain the proprietary Python code for our automated test system Maintain+ expand our Jenkins scripting to improve our automated test suite Create new automation scripts for complex testing requirements (stress tests, performance tests, special features, etc) Create and maintain an image diffing test suite Develop test plans and design automated tests using our proprietary test system Perform manual testing on new features for software releases when needed Communicate with other team members across time zones Be a resource for others to learn from about how to use our test system Help to document our test system for internal and external users Minimum Qualifications: BA/BS in Computer Science OR equivalent work experience At least 3 years work experience coding in Python and C++ (or similar coding languages) At least 3 years’ experience with testing 3D graphics applications and/or content creation tools Solid understanding of 3D graphics concepts Good eye that can notice both technical and aesthetic problems with software Experience with writing automated tests Strong experience using command prompts (DOS, bash, etc) Experience with project management for software using Jira (or similar) Detail oriented with strong organizational and communication skills and tenacity to follow through Eligibility to work with export-controlled technology Bonus Points: Video Game / 3D graphics testing experience Experience with flight simulation software Experience with VR or MR headset configuration/testing Experience with creating image diff tests Experience with Jira, Perforce, Visual Studio, Jenkins, Bash, GitHub Experience writing technical documentation Basic knowledge of 3D modeling, GIS, Geospatial or Geotypical content creation We offer a very attractive compensation package including competitive base salary, company performance-based profit sharing, 401k, 100% employer paid health benefits (medical, dental, vision, life, std, ltd, and life insurance plans). No relocation reimbursement provided. For more information about our company, please visit www.aechelon.com Aechelon Technology is an equal opportunity employer. We are committed to providing access and opportunities to individuals with disabilities. If you are an applicant who is unable to fully utilize/access our application process because of a disability, Aechelon Technology will provide a reasonable accommodation. Please send an email to hr_team@aechelon.com to request that accommodation, and please be sure to include a detailed description of your requested accommodation, your name and preferred method of contact. This position description is not intended to be a complete listing of activities, duties or responsibilities that are required of the employee holding this position. Duties, responsibilities and activities may be changed or others may be assigned at any time by the Company with notice to the employee. Aechelon Technology is an equal opportunity employer. We are committed to providing access and opportunities to individuals with disabilities. If you are an applicant who is unable to fully utilize/access our application process because of a disability, Aechelon Technology will provide a reasonable accommodation. Please send an email to hr_team@aechelon.com to request that accommodation, and please be sure to include a detailed description of your requested accommodation, your name and preferred method of contact.

Posted 3 weeks ago

Timenow logo
TimenowIndianapolis, Indiana

$72,000 - $86,000 / year

Benefits: 401(k) Dental insurance Health insurance Paid time off Training & development Vision insurance 401(k) matching Location: Indiana Industry: Petrochemical, Project Management Consulting Reports To: Program or Portfolio Director / Operations Manager Job Summary:Ensures all construction work on chemical industry projects meets the required quality standards, codes, and specifications through rigorous inspections, documentation, and corrective action follow-up. Key Responsibilities: Perform inspections and audits to verify compliance with project specifications, codes, and standards. Develop and maintain quality documentation, including ITPs (Inspection & Test Plans). Report non-conformances and follow through on corrective actions. Liaise with client representatives, contractors, and engineers on quality-related matters. Maintain accurate quality control records for turnover packages. Qualifications: Technical diploma or degree in Engineering or Quality Management. 5+ years in QA/QC roles within industrial or chemical projects. Familiarity with ISO standards, ASME codes, and API requirements. Strong attention to detail and documentation skills. Skills & Competencies: Expertise in inspection techniques and quality systems. Strong documentation and record-keeping abilities. Good understanding of welding, piping, and mechanical standards. Analytical thinking for defect/root cause analysis. Clear communication skills for technical reporting. Proficiency in MS Office and QA/QC software. Languages: Fluent in English Compensation: $72,000.00 - $86,000.00 per year 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. About Us Experiencing exponential growth in the United States, Timenow is the largest Project Management Company in the private sector in Brazil.Driven by results, we are the connection of people from different cultures in different places around the world with the knowledge we have built along our journey. Focused on the vision of being leaders in digital transformation in the project management segment, our team works daily with Commitment, Originality, and Integrity, always Valuing People to deliver our promise: Imagining a possible world and engineering it. We are an Engineering Consultancy Company with over 2000 employees worldwide. Driven by results, we are the connection of people from different cultures, in different places around the world, with the knowledge we have built along our journey. Focused on the vision of being leaders in digital transformation in the project management segment, our team works daily with Commitment, Originality and Integrity, always Valuing People, to deliver our promise: Imagining a possible world and engineering it.

Posted 1 week ago

V logo
Vantive ManufacturingDeerfield, Virginia

$120,000 - $150,000 / year

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Your Role We are seeking a seasoned Technical Lead to serve as the IT system owner and principal technical authority for TrackWise (Sparta Systems/Honeywell) and adjacent Quality/Regulatory applications. The role is responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle This is a high-visibility, hands-on leadership role responsible for the stability, configuration, integration, and lifecycle management of the enterprise QMS platform at Vantive. The ideal candidate brings deep TrackWise configuration experience coupled with modern full-stack engineering skills to drive reliability, scalability, and compliant change. What You’ll Be Doing Product & System Ownership Serve as IT system owner for TrackWise, accountable for end-to-end technical health, roadmap, and lifecycle. Own incident/problem/change processes (ITIL) and SLAs; lead major incident triage and root-cause analysis. Coordinate with vendor (Sparta Systems/Honeywell) for patches, upgrades, and support cases; manage risk and release notes impact assessments. Configuration & Platform Engineering Design, configure, and extend TrackWise workflows, forms, business rules, records, and security/roles. Engineer robust integrations with ERP/MES/PLM/Labeling and other QA/RA systems (e.g., complaints, CAPA, audits) using Java/.NET and SQL Server; leverage scripting/automation where applicable. Leverage AWS for hosting patterns, automation, and resiliency (e.g., EC2, S3, RDS/SQL Server on AWS, IAM, CloudWatch). Validation, Compliance & Audit Readiness Operate within GxP and 21 CFR Part 11 requirements: lead Computer System Validation (CSV) deliverables. Maintain validation plans, IQ/OQ/PQ scripts, traceability matrices, risk assessments, and change controls. Support internal/external audits; ensure procedures, SOPs, and records are current and inspection ready. Stakeholder Management & Leadership Engage business SMEs across Quality and Regulatory to capture requirements and translate to scalable technical solutions. Communicate status, risks, and decisions effectively to leadership; influence cross-functional priorities. What You’ll Bring Bachelor’s degree in computer science, Information Systems, Engineering, or related field; Master’s a plus. 7–10+ years of total IT experience with increasing responsibility in enterprise applications and integrations. Demonstrated success leading technical delivery in highly regulated industries (medical device, pharma, biotech). 3–5+ years of hands-on TrackWise configuration and administration (workflows, forms, rules, security, records, reporting). 2–3+ years of modern full-stack engineering with one or more: Java or .NET; strong SQL (Microsoft SQL Server); scripting (PowerShell). Experience with Docker containers and AWS services for hosting, automation, monitoring, and resilience. Proven delivery in validated (GxP) environments with 21 CFR Part 11 controls: strong change control and SDLC discipline. Solid understanding of performance engineering, observability, and incident/problem management (ITIL). Excellent communication, stakeholder management, and technical leadership; ability to mentor and set engineering standards. Technical Stack TrackWise (Sparta Systems/Honeywell). Java or .NET (C#), REST/SOAP services, JSON/XML. Microsoft SQL Server (T-SQL), performance tuning, stored procedures. AWS (e.g., EC2, S3, IAM, CloudWatch) and on-prem connectivity patterns. Docker; scripting/automation with PowerShell; optional Node.js or front-end technologies for UI extensions. Source control and CI/CD (e.g., Git, Azure DevOps/GitHub Actions); environment promotion under CSV constraints. Preferred Skills TrackWise upgrade/migration experience (major version changes, remediation planning, vendor coordination). Hands-on with event-driven architectures, message queues, or integration platforms (e.g., MuleSoft, Boomi). Exposure to other QA/RA systems (e.g., Veeva QMS/RA, Labeling, PLM) and data exchange patterns. Experience with ServiceNow/ITSM, Agile methods (Scrum/Kanban), and regulated SDLC toolchains. Security-by-design mindset (identity/role design, audit trails, segregation of duties). Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $120,000 to $150,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position is also eligible for a discretionary bonus. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. US Benefits at Vantive This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive Equal Employment Opportunity Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .

Posted 2 weeks ago

Guidehouse logo
GuidehouseTysons Corner, Virginia
Job Family : Systems & Business Integration Consulting Travel Required : None Clearance Required : Ability to Obtain Public Trust What You Will Do : Guidehouse Quality Assurance (QA) Testers play a key role in ensuring the quality and reliability of software solutions across client engagements. They work closely with developers, analysts, and project managers to design and execute test plans that validate functionality, performance, and usability. Our QA Testers are expected to be detail-oriented, proactive, and collaborative, with a strong understanding of testing methodologies and tools. They contribute to the full software development lifecycle and help identify issues early to ensure smooth delivery and client satisfaction. They also apply automation testing techniques to improve efficiency, coverage, and repeatability across test cycles. Responsibilities include the following: Collaborate with development and business teams to understand application requirements and define test strategies. Design, develop, and execute manual and automated test cases. Perform functional, regression, integration, and user acceptance testing. Document defects clearly and track them through resolution. Maintain test documentation including test plans, scripts, and reports. Participate in sprint planning and agile ceremonies to align testing with development cycles. Support continuous improvement of testing processes and tools. Ensure applications meet performance, usability, and accessibility standards. Contribute to an environment where people and technology thrive together to accomplish more than they could apart. Develop and maintain automated test scripts using tools such as Selenium, Postman, or similar. Integrate automated tests into CI/CD pipelines to support continuous testing. What You Will Need : Bachelor’s degree in Computer Science, Information Systems, or a related field. Minimum THREE (3) years of professional experience in software testing or QA. Experience with testing tools such as Selenium, JUnit, Postman, or similar. Familiarity with Agile/Scrum development environments. Strong understanding of software development lifecycle and testing methodologies. Experience with test automation frameworks and scripting. Excellent analytical and problem-solving skills. Strong communication and documentation abilities. US Citizenship and the ability to obtain and maintain Public Trust. What Would Be Nice To Have : Experience in a consulting or client-facing role. Exposure to federal government software projects. Experience with performance and load testing tools. Familiarity with Appian platform or federal financial systems. Knowledge of accessibility compliance (e.g., Section 508). Experience with CI/CD pipelines and DevOps practices. Familiarity and/or experience implementing with low-code platforms. Experience working in an agile development environment. Recent work experience on data projects in a federal government setting. Understanding of responsible AI principles and model interpretability. #LI-DNI What We Offer : Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: Medical, Rx, Dental & Vision Insurance Personal and Family Sick Time & Company Paid Holidays Position may be eligible for a discretionary variable incentive bonus Parental Leave and Adoption Assistance 401(k) Retirement Plan Basic Life & Supplemental Life Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts Short-Term & Long-Term Disability Student Loan PayDown Tuition Reimbursement, Personal Development & Learning Opportunities Skills Development & Certifications Employee Referral Program Corporate Sponsored Events & Community Outreach Emergency Back-Up Childcare Program Mobility Stipend About Guidehouse Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process. If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties. Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

Posted 1 week ago

Aviagen logo
AviagenElkmont, Alabama
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 2 weeks ago

Genentech logo

QA Specialist II/III, Customer Complaints

GenentechHillsboro, Oregon

$77,000 - $174,000 / year

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.1

Reclaim your time by letting our AI handle the grunt work of job searching.

We continuously scan millions of openings to find your top matches.

pay-wall

Job Description

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Operations organization at HTO produces millions of units of life-saving medicine every year for patients around the world.

The Opportunity:

In this exciting role, you will be part of a dynamic and inclusive team. You will act as lead investigator for complaints, critical deviations and the associated escalation process.You will be a mentor and coach for the organization and the network and you will provide quality oversight for our commercial production and the complaints at the Hillsboro site.

  • You will lead complaints and critical deviations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions and follow company standards. 

  • You will own and/or support complaint trending activities including, but not limited to annual product quality reviews and quarterly trending reports.

  • You will collaborate with departments (e.g. Affiliates, Manufacturing sites, external quality, quality control etc.) to establish appropriate, efficient, and timely investigation plans. 

  • You will notify senior management of potential quality or regulatory issues that may impact product quality or regulatory compliance.

  • You will communicate new and updated regulatory requirements and evaluate systems in place.

  • You will support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures. 

  • You will solve complex problems; both inside and outside of the quality organization

  • You will work independently within standard guidelines, policies and health authority regulations and mentor others

  • You will serve as primary consultant to senior management and internal/external spokesperson for the organization

Who you are:

  • You have a BS/MS Master's degree (Life Sciences or Engineering, preferred) and significant relevant bio/pharmaceutical experience in a Good Manufacturing Practices environment (Drug Product and/or Device preferred) 

  • You have 4+ years (level II) and 8+ years (level III) of industry experience preferably in a biologics manufacturing environment  

  • You are able to deliver business outcomes in support of departmental and site objectives. 

  • You are able to work in an agile organization, flow to work and apply skills where resources are needed

  • You have sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to commercial manufacturing. 

  • You have excellent communication skills and are able to gown into production space 

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $77,000 - $143,000 (for level II) and $94,000 - $174,000 (for level III). Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

pay-wall