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Location: Portsmouth, NH Join our Quality Assurance team and play a key role in ensuring GMP compliance and operational excellence. You’ll be part of a collaborative environment where your expertise helps deliver life-changing therapies. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Competitive compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to our global benefits: https://www.lonza.com/careers/benefits . What you will do: Provide real-time Quality Assurance support on the manufacturing floor. Review GMP documentation and observe operational practices. Offer guidance on routine and non-routine GMP issues. Respond to QA hotline calls and escalate complex issues. Authorize equipment release and manage quality tag-outs. Apply data integrity principles in all aspects of work. Represent QA in meetings and project teams. What we are looking for: Bachelor’s degree in a science-related field or equivalent experience. 5–10 years of cGMP experience in a regulated environment. Strong understanding of GMP and ICH guidelines. Familiarity with systems such as TrackWise, SAP, LIMS, and Microsoft Office. Ability to identify and escalate quality issues promptly. Collaborative mindset and commitment to continuous improvement. Excellent communication and problem-solving skills. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Job Title: Associate QA Project Lead Requisition ID: R026229 Job Description: The Associate QA Project Lead is responsible for overseeing the day-to-day operations on the test floor, acting as an extension to the assigned QA Project Lead by assisting with the responsibilities of guiding a team of QA Testers through the functionality testing and/or 1st party compliance testing of an Activision product. The Associate QA Project Lead may also be called upon to perform in an acting QA Project Lead role, including organizing and leading the testing effort on assigned pre-release video games as well as being the main point of contact between Production staff, Development teams, and other Activision QA groups. Duties and Responsibilities: Project Management Assists and makes recommendations to the QA Project Lead in overall project management including fielding and assigning out tasks, and tracking test team effectiveness and issues across the project. Assists and makes recommendations to the QA Project Lead with the creation and maintenance, and auditing within DevTest. Assists and makes recommendations to the QA Project Lead with the completion of milestone assessment reports at Alpha & Beta in accordance with QA policies. Collaborates with and makes recommendations to the QA Project Lead in creating informative and accurate daily reports and may be called up to ensure consistent distribution to designated Production and Management staff. Contributes towards the development of effective test plans and performing standard testing on console games to verify proper function, data content, performance, usability/playability, and hardware/software compatibility. Assists in special projects, such as demonstrations, training, surveys, focus groups, etc. Assists in forming and improving QA systems and procedures by making recommendations to Leads, Sr. Leads, and Managers Manages the test team on a day-to-day basis, and occasionally serves as Lead in the QA Project Lead's absence. Database Administration Assists the QA Project Lead with a review of all issues entered by the test teams to ensure bug reports include required information and conform to Activision QA standards. Tracks high severity issues across the project to ensure that they are resolved for submission. Independently reviews and assigns out NMI issues to testers to ensure swift updates to developer and Production questions regarding issues. Assists the QA Project Lead with initial research and evaluation of all disputed (‘Not a Bug,’ ‘Will Not Fix,’ & ‘Duplicate’) issues. Updates the database after each bug sweep. Managing and Mentoring Monitors the defect report database and other platform associated databases. Provides direct supervision of the test team on a day-to-day basis to ensure rapid and accurate completion of assigned tasks. Evaluates tester performance and recommends promotions or remediation plans to the Project Lead. Coaches testers to alleviate any issues that arise. Prepares testers for additional responsibilities, such as Senior QA Testers. Requirements: Technical Proficient with Devtrack & Jira or similar bug tracking database. Able to identify defects in software titles and report defects in a clear and concise manner. Capacity to create and implement innovative testing procedures and materials. Strong working knowledge of most popular console platforms and related peripherals, PC Software/hardware, and Microsoft Office (Outlook, Word, Excel). Has been in a leadership role (Senior QA Tester and/or Acting Associate QA Project Lead). Non-Technical 1+ year of experience working in the Activision QA Department or in a comparable Quality Assurance department. Possesses excellent spoken and written communication skills and be able to work with varied staff members and personalities. Proficient in exercising independent judgment in supervising others and/or making meaningful recommendations to senior managers with respect to decisions concerning personnel and team management. Strong leadership skills and the ability to mentor new employees. Ability to handle high pressure situations and have strong prioritization skills. Must be punctual, proactive, and have a strong work ethic. Able to work in a team environment. Actively communicates a positive, outgoing approach to Quality Assurance. Able to give and accept positive feedback as well as constructive criticism. Must be an avid gamer, with interests in many different genres of games and a passion for developing high quality games. A strong desire to learn and understand the technologies involved in game creation. Our World At Activision, we strive to create the most iconic brands in gaming and entertainment. We’re driven by our mission to deliver unrivaled gaming experiences for the world to enjoy, together. We are home to some of the most beloved entertainment franchises including Call of Duty®, Crash Bandicoot™, Tony Hawk’s™ Pro Skater™, and Guitar Hero®. As a leading worldwide developer, publisher and distributor of interactive entertainment and products, our “press start” is simple: delight hundreds of millions of players around the world with innovative, fun, thrilling, and engaging entertainment experiences. We’re not just looking back at our decades-long legacy; we’re forging ahead to keep advancing gameplay with some of the most popular titles and sophisticated technology in the world. We have bold ambitions to create the most inclusive company as we know our success comes from the passionate, creative, and diverse teams within our organization. We’re in the business of delivering fun and unforgettable entertainment for our player community to enjoy. And our future opportunities have never been greater — this could be your opportunity to level up. Ready to Activate Your Future? The videogame industry and therefore our business is fast-paced and will continue to evolve. As such, the duties and responsibilities of this role may be changed as directed by the Company at any time to promote and support our business and relationships with industry partners. We love hearing from anyone who is enthusiastic about changing the games industry. Not sure you meet all qualifications? Let us decide! Research shows that women and members of other under-represented groups tend to not apply to jobs when they think they may not meet every qualification, when, in fact, they often do! We are committed to creating a diverse and inclusive environment and strongly encourage you to apply. We are committed to working with and providing reasonable assistance to individuals with physical and mental disabilities. If you are a disabled individual requiring an accommodation to apply for an open position, please email your request to accommodationrequests@activisionblizzard.com. General employment questions cannot be accepted or processed here. Thank you for your interest. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, gender identity, age, marital status, veteran status, or disability status, among other characteristics. Rewards We provide a suite of benefits that promote physical, emotional and financial well-being for ‘Every World’ - we’ve got our employees covered! Subject to eligibility requirements, the Company offers comprehensive benefits including: Medical, dental, vision, health savings account or health reimbursement account, healthcare spending accounts, dependent care spending accounts, life and AD&D insurance, disability insurance; 401(k) with Company match, tuition reimbursement, charitable donation matching; Paid holidays and vacation, paid sick time, floating holidays, compassion and bereavement leaves, parental leave; Mental health & wellbeing programs, fitness programs, free and discounted games, and a variety of other voluntary benefit programs like supplemental life & disability, legal service, ID protection, rental insurance, and others; If the Company requires that you move geographic locations for the job, then you may also be eligible for relocation assistance. Eligibility to participate in these benefits may vary for part time and temporary full-time employees and interns with the Company. You can learn more by visiting https://www.benefitsforeveryworld.com/ . In the U.S., the standard base pay range for this role is $19.23 - $35.58 Hourly. These values reflect the expected base pay range of new hires across all U.S. locations. Ultimately, your specific range and offer will be based on several factors, including relevant experience, performance, and work location. Your Talent Professional can share this role’s range details for your local geography during the hiring process. In addition to a competitive base pay, employees in this role may be eligible for incentive compensation. Incentive compensation is not guaranteed. While we strive to provide competitive offers to successful candidates, new hire compensation is negotiable.

Michels Road & Stone, Inc. is shaping the future. We provide and place materials for road, airport, mass excavation and shoreline protection projects. Our projects are large; the tolerance for error is tiny. Our leaders, field crews and massive fleet of specialized equipment is focused on excellence. Are you? Our work improves lives. Find out how a career at Michels Road & Stone, Inc. can change yours. As a Quality Assurance/Quality Control technician you would assist the project manager with quality assurance and technical assignments including material, concrete, and soil testing. Additional duties include analyzing and evaluating jobsites conformance to bid specifications. You will also prepare reports detailing tests conducted, determine results and conduct inspections of construction sites to determine conformance of sites to design specifications. Why Michels Road & Stone, Inc.? We will never ask you to prioritize speed ahead of safety We are family owned and operated We invest an average of $5,000 per employee on training each year We share experience and insights to develop industry leaders We are a part of the Michels family of companies – one of North America’s largest, most diversified energy and infrastructure contractors We offer a comprehensive benefits program, including Health, Dental, Life, Flexible Spending Accounts, Health Savings Account, Short Term and Long Term Disability Insurance, 401(k) plan, Legal Plan, and Identity Theft and Monitoring Plan. Depending on your position and location you may participate in a different benefit plan. Why you? You thrive in fast-paced environments under tight deadlines You relish new challenges and evolving technology You enjoy collaborating and communicating with your teammates You like to know your efforts are noticed and appreciated You enjoy working independently What it takes: 1-3 years of related concrete quality experience Thorough understanding of Microsoft Word and Excel Safety minded Effective verbal and written communication skills Travel Required Ability to travel as needed to different sites AA/EOE/M/W/Vet/Disability https://www.michels.us/website-user-privacy-policy/

Job Summary: Manage the QA Analytical function at the KBI Biopharma, Hamlin location, supporting analytical laboratory operations in a contract biopharmaceutical manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with AFS, QC and Microbiology laboratories to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Cultivates and maintains Quality Assurance staff by recruiting, training, and managing QA team members. Align QA Analytical organization to meet company’s strategic goals. Experience managing a QA organization in both clinical and commercial operations is beneficial Job Responsibilities: Leads and directs the QA Analytical team supporting analytical testing operations. Lead, assess, coach and develop departmental specialists. Manage performance, ensure team meets expectations and objectives. Guide the professional growth of team members by providing personal guidance and training relative to responsibilities Support GMP testing activities including release and stability testing. Oversees QA review of method qualifications, transfer, and validations. Oversees QA review of deviations, lab investigations, SOPs and GMP technical documents. Works directly with AFS and Microbiology to resolve deviations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Attend relevant operational meetings in support of issue resolution and escalation and batch disposition activities. Support client audits and regulatory inspections as required. Job Requirements: Knowledge, Skills, Abilities BS in scientific field with 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent. Experience in a in a QA role supporting GMP analytical testing is required. Minimum of 2 years of supervisory experience. Strong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs and knowledge of US, EU and Row cGMP guidelines. Experience with electronic laboratory information management systems is preferred. Language 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. Reasoning Ability 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. Math Ability Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Physical Demands Support manufacturing and warehouse operations to include movement and/or lifting of raw materials and consumables. Computer Skills Knowledge of and experience using word processing, databases, spreadsheets, Power Point, Internet, E-mail, Calendar Management Equipment Knowledge of and experience using a computer, a telephone KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching , and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com . KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. 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.

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. 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 Civil Structure Architecture QA Inspector to support us with the development of multiple data center projects for one of the top technology clients in the world. This is a client-facing role that requires strong interpersonal, communication, and organizational skills, the ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently and across multiple regions. 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 implementation and management of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction inspection and testing services of a project. The Civil Structure Architecture QA Inspector is accountable for the guarantee of the work performed, 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 Develop a sound knowledge of the project scope and requirements. Ensure compliance with stringent contract and owner quality requirements. Prepare comprehensive, project-specific QC plans. Review and verify material submittals for A/E and Client review. Verify delivered materials comply with approved submittals. Provide and review submittals, RFI logs, maintenance logs, and other project-related materials in a timely manner. Review and update QC punch lists and coordinate punch list completion with GC and subcontractors. Verify the implementation and operation of the quality assurance and control systems by planning and conducting internal quality audits and inspection of activities on site. Ensure implementation and continuous improvement in overall Quality Systems. Ensure that all contractual / company and local authority requirements for Quality, Health, Safety & Environment (HSE) requirements are complied with. Review, update, and verify the distribution of the Quality Management Procedure, Quality Manual, and related procedures for Infrastructure, MEP, Civil, and other subcontractors and divisions by the GC. Verify that GC implements adequate training/awareness of company personnel for Quality systems. Ensure that all non-conformance issues are promptly investigated, corrective and preventive actions are proposed/implemented, and are quickly closed out. Ensure that the contractual quality requirements of a project are fully communicated to all key personnel, so that their roles in fulfilling these requirements are fully understood. Ensure that all GC and subcontractors' quality systems and plans are acceptable to the company as applicable to the "Project Contract". Ensure that Subcontractors'/Suppliers' quality systems are implemented and effective. Ensure that the calibration of all inspection, measurement, and test equipment is conducted according to the defined schedule. Conduct reviews of the approved suppliers and subcontractors' list. Liaise with the General Contractor, Client, and Project Management team to ensure that all potential and actual quality issues are fully resolved. Establish a strong relationship with the GC and Client, and communicate with both technical and management-level personnel. Prepare PowerPoint decks and present to management on progress, findings, and recommendations. Review project plans, requirements, and specifications. Perform other related duties as required and assigned. QUALIFICATIONS Required Qualifications : 15+ years of construction quality management experience. Bachelor's degree in Civil, Structural, Architectural Engineering, or a related field. Experience with managing field engineering, inspection, and NDE related to all QA/QC functions. Ability to develop and manage non-conformance, deficiencies, and reporting programs, including root cause analysis. Experience in developing and monitoring of project QA/QC budgets. Ability to ensure that correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded. Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor. Experience working as a QA/QC Manager for large Commercial, Industrial, or Mission-Critical Facilities construction projects. An excellent understanding of construction Quality Management Systems (QMS). Experience developing various types of reports, targeting different audiences. Experience in client-facing positions. Demonstrated ability to understand technical and complicated construction programs and the ability to communicate progress to both technical and management-level personnel. Strong communication skills, including the ability to communicate with any audience clearly and accurately. Proficient in Microsoft Office programs. Preferred Qualifications: Project Management Professional (PMP) certification. Certified Construction Manager (CCM) certification. Strong background in data center development and construction. POSITION DETAILS: Primary Location (On-site): Multiple Sites Conesville, Ohio Atlanta, Georgia Phoenix, Arizona Shippingport, Pennsylvania Frederick, Maryland Dallas, Texas Position: CSA 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 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.

Description Procon is a top-ranked construction management and technology consulting firm with 25 years of experience delivering high‑impact projects across the U.S. and worldwide. An ENR Top 100 CM/PM firm for five consecutive years, we specialize in program management, project controls, commissioning, and virtual intelligence—and offer an excellent platform to grow your career while shaping the future of the built environment. Procon now seeks a Electrical QA Representative for a long term opportunity in the Pullman, WA area. The ideal candidate will have 8 years or more of experience conducting mechanical inspections on new construction and renovations of buildings. The ideal candidate will review blueprints, monitor construction progress, examine interior/exterior work, utilizing survey instruments to verify completed work, taking photographs and maintaining a log. This role requires various skills and experience as listed below. Requirements Qualifications & Skills Must have 8 years of experience as an electrical inspector with at least one project over $50M in dollar amount. Bachelors in electrical engineering degree or related field is required for less than 10 years of experience. Must have experience with government construction. Government or military project experience is preferred. Must have excellent communication and problem-solving skills. A high school diploma or equivalent is required for all candidates. OSHA 30 Hour Certification is preferred. Experience with Prolog Construction Management software is preferred. Ability to obtain CQM certification within the first 1st month of employment. Ability to work on site is required. Responsibilities & Duties Coordinate and facilitate all construction activities related to the General Contractor (GC) and Client. Provide assistance for any and all contract issues related to mechanical systems on all phases of the design-build contract. Provide daily onsite field representation to monitor construction contractor performance and inspect work in accordance with specifications and drawings. Provide technical expertise of the products/materials being installed in the project. Monitor all construction activities scheduled with emphasis on milestones, phasing/ sequencing, submittals, efficient and balanced work flow, major test and any unique requirements needing special schedule or tracing. Monitor project for cleanliness. Monitor and inspect the GC for compliance with current safety regulations, standards, project safety plan and report any non-compliance to the Client. Immediately notify the Client when any life threatening conditions are observed, and provide assistance as necessary to remedy such situations. Provide electronic daily reports of the contractor’s and sub-contractors’ work activities witnessed during site monitoring. Provide summary of and discrepancies from the requirements of the Contract Documents. Provide daily site photos to be saved electronically at a designated location on the Client’s network. Provide support to the Senior Project Manager in all design reviews prior and during construction. Provide pre-construction, during construction and post-construction photos of the site. Provide project coordination and construction quality assurance services for the technical aspect of the project. The inspector shall physically verify correct materials delivered and/or in secured storage on or off site, proper materials installed, and percentage of work satisfactorily completed and in place and provide this information to the CM. Benefits Salary commensurate with experience. Interested and qualified candidates please submit a cover letter and a resume. Procon offers competitive salaries and a comprehensive benefits package, including full medical/dental insurance and 401(K) plan. Procon is an equal opportunity employer and considers qualified applicants for employment without regard to race, gender, age, color, religion, disability, veteran status, sexual orientation, or any other protected factor.

Nature and Scope This position is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Procedures. The Batch Record reviewer ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations. The Batch Record reviewer works under the direct supervision of the QA Supervisor. 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. Execute timely reviews all batch documentation for accuracy and completeness according to cGMP’s. Execute batch record review and review of supporting systems including Veeva Vault and Trackwise. Adheres to internal and external guidelines, specifications and regulatory requirements while reviewing batch documentation. Ensures all work in performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements. Work with area personnel to resolve errors and/or discrepancies. Assures all errors and corrections are resolved according to SOP requirements. Enter data into applicable spreadsheets/databases. Update metric reporting as needed. Submit error free batch records to release for product shipments. Execute batch record review of Media Fills and Research and Development (R&D) batches. Review and approve preliminary batch records after batch record assembly. Review logbooks for accuracy after creation. At any time may be required to perform the job responsibilities for the Documentation Specialist. 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. High School Diploma or GED equivalent required. Associates or Degree, preferred. Minimum 3 years’ experience preferred in QA in a cGMP manufacturing environment. Experience in QA, Compliance, Auditing in a cGMP manufacturing environment is preferred. Demonstrated success in managing multiple activities at the same time and producing outstanding results. Skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Strong attention to detail and adherence to Standard Operating Procedures (SOPs). Ability to take feedback constructively and function in a team-oriented work environment. Ability to work overtime as needed. Physical Environment and Requirements Employee must be able to occasionally lift and/or move up to 25 pounds. Expected Hourly Rate: $21.06 - $24.00 The hourly rate displayed is the hourly rate of compensation 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 .

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 Electrical 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 Electrical 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 an Electrical QA/QC 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): Frederick, Maryland Position: Electrical 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.

Job Title: QA Automation Manager Location: Atlanta, GA | NYC, NY | or Remote Employment Type: Full-time, Exempt Reports to: Sr. Director – QA Who We Are Impiricus is the first and only AI-powered HCP Engagement Engine. Founded by a practicing physician and a senior pharmaceutical executive, Impiricus was created to cut through the noise and put physician care delivery at the forefront. With our unique frontline access to HCPs, their insights, and clinical expertise, we are committed to providing life science companies with innovative channels and AI technology needed to deliver clear, reliable, and evidence-based resources into the hands of HCPs. Guided by a board of trusted physician advisors, we ensure every message leads to better patient care. Welcome to the future of ethical physician and pharma collaboration! Job Summary: As a QA Automation Manager at Impiricus, you will ensure the delivery of high-quality, secure, and reliable software products across all teams and platforms. You will lead and develop a team of QA engineers, guiding both manual and automated testing efforts to validate features, maintain stability, and support compliance with industry standards. In collaboration with product managers, developers, data teams, and executive leadership, you will drive quality strategy, standardize QA practices, and proactively identify opportunities for improvement within our Agile environment. Your leadership will strengthen our testing lifecycle, elevate automation maturity, and promote a culture where every employee advocates for quality—directly contributing to innovation and exceptional user experiences across Impiricus products. Duties / Responsibilities: Testing and Team Management Lead, mentor, and develop a team of QA Engineers across manual and automation specialties. Define responsibilities, review work quality, and provide coaching and performance feedback. Review detailed test plans, test cases, and test scripts to ensure thorough coverage of requirements. Manage team capacity, workload distribution, and deliverables Identify, log, and track defects through resolution, collaborating with developers to address issues promptly. Process Ownership and Improvement Establish, document, and maintain QA standards, guidelines, and best practices. Drive proactive Quality Advocacy across all teams. Oversee test planning, execution, and coverage for new features and releases. Ensure consistency in test case structure, documentation, and readiness. Automation Leadership Lead expansion of automation frameworks and practices for all platforms. Identify automation candidates and prioritize automation backlog. Provide regular updates to stakeholders on automation progress and results. Experience: Bachelor’s degree in Computer Science, Engineering, or a related field (or equivalent experience). 5+ years of experience in software QA, preferably in the health tech industry. 2+ years of experience leading a team of QA engineers. Strong understanding of Agile methodologies and CI/CD pipelines. Experience with manual and automated test planning, development, and execution. Proficiency in scripting languages such as Python, JavaScript, or similar. Familiarity with API testing tools and frameworks. Knowledge of healthcare regulations (HIPAA, FDA, GDPR). (Preferred) SQL skills for database validation and troubleshooting. Proven ability to work in a fast-paced, dynamic environment with minimal supervision. The base salary range for this role is $130,000 - $140,000. Where you land within the range will reflect your skills, experience, and location, while keeping team parity in mind and leaving room for future growth. Benefits: Impiricus focuses on taking care of our teammates’ professional and personal growth and well-being. Healthcare : Medical, dental, and vision coverage for you and your dependents + on-demand healthcare concierge HSA, FSA & DCFSA : Pre-tax savings options for healthcare and dependent care, with monthly employer contributions to HSA (if enrolled in a high-deductible plan) Coverage & Protection : 100% paid short- and long-term disability, plus life and AD&D insurance Flexible Time Off : Take the time you need with a flexible vacation policy — recharge your batteries your way Parental Leave : 12 weeks of paid leave to spend time with your newborn, adopted, or foster child (available after 6 months) Your Work, Your Way : If you’re close to an office, we encourage spending some time in-person to collaborate and connect. If not, remote is always an option. Home Office Setup : We’ll ship you the gear you need to create a comfortable workspace at home. 401(k) : Save for your future with tax advantages (and company match!) Impiricus provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 .

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.

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.

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!

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.

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.

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.

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

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 .

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.