Quality Assurance Engineer

Job Title:

Quality Assurance Engineer - External Job Description The Quality Assurance Engineer - External plays a key role in overseeing external quality operations, with a focus on Contract Manufacturing Organizations (CMOs), material suppliers, service providers, and contract laboratories. You will assess compliance with current Good Manufacturing Practices (cGMPs), review batch records and change controls, and ensure adherence to applicable regulations and internal policies. This role combines supplier auditing, quality oversight, and performance monitoring, and requires periodic travel. Responsibilities Conduct external quality assurance activities for CMOs, material suppliers, service providers, and contract laboratories to ensure compliance with cGMPs, applicable regulations, and internal company policies. Ensure suppliers meet industry and company standards as defined by regulatory agencies and internal standard operating procedures (SOPs). Oversee supplier qualification activities and verify they follow established policies and meet all regulatory requirements for relevant government agencies. Assist in developing, maintaining, and executing audit schedules for external suppliers and partners, and perform on-site and remote audits as needed. Review and approve manufacturing and laboratory deviations, batch documentation, Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, and change requests from suppliers. Conduct thorough batch record reviews, including all associated documentation required for product release such as deviations, change controls, and validation documentation. Trend and analyze performance metrics for suppliers, and report regularly to identify potential shifts in supplier performance before supply is impacted. Track post-audit improvement actions, monitor progress, and provide regular updates on implementation status. Perform effectiveness audits of implemented corrective and preventive actions to confirm that identified issues are resolved and controls are sustained. Identify, evaluate, and present evidence of quality and compliance risks to Quality Assurance management as they arise, including risks related to Quality Agreements, registration batches, stability programs, Process Validation (PV), and product launches. Assist with the management of Supplier Corrective Action Requests (SCARs) for third-party products, ensuring timely follow-up and closure. Support changes involving CMOs and contract packaging organizations (CPOs), including review of batch records and validation documentation. Generate supplier performance metrics and contribute to quality system management reviews by presenting relevant data and trends. Collaborate closely with internal stakeholders such as Sourcing/Supply Chain, Quality Assurance, and Quality Control teams, as well as external partners, to maintain robust supplier quality oversight. Essential Skills Bachelor's degree (BS) in a scientific discipline or a related field, or an equivalent combination of education and experience. 5+ years of pharmaceutical quality assurance experience in a GMP manufacturing environment; 10+ years of experience preferred. Demonstrated experience in external and supplier auditing within a pharmaceutical or GMP-regulated environment. Thorough experience with batch record review, including all associated documentation required for product release such as deviations, change controls, and validation documentation. Strong knowledge of current Good Manufacturing Practices (cGMPs) and regulatory expectations for pharmaceutical manufacturing. Proven experience in quality auditing, including planning, executing, and documenting audits of external suppliers and partners. Ability to interpret and apply internal SOPs, quality agreements, and regulatory requirements to supplier oversight activities. Willingness and ability to travel internationally 1-2 times per year, with a valid passport. Willingness and ability to travel domestically for audits approximately 3-4 times per year. Strong attention to detail and ability to identify, assess, and communicate quality and compliance risks. Effective communication and collaboration skills for working with internal cross-functional teams and external partners. Additional Skills & Qualifications Experience auditing a variety of facility types, such as aseptic manufacturing, packaging operations, laboratories, and component or ingredient suppliers. Experience developing and maintaining audit schedules and tracking post-audit corrective and preventive actions. Familiarity with managing Supplier Corrective Action Requests (SCARs) and monitoring effectiveness of implemented actions. Experience generating and trending supplier performance metrics and presenting results in quality system management reviews. Ability to work effectively in a team of quality professionals and contribute to a collaborative, solution-oriented environment. Work Environment The standard work schedule is Monday through Friday, typically from 8:00 a.m. to 4:30 p.m., with some flexibility on start and end times. The environment emphasizes cross-functional collaboration, structured quality systems, and regular interaction with global and domestic suppliers. Job Type & Location This is a Permanent position based out of Bridgeton, MO. Pay and Benefits The pay range for this position is $90000.00 - $120000.00/yr. 401K, PTO, Health, Medical, Dental, Vision, Bonus program, pet insurance Workplace Type This is a fully onsite position in Bridgeton,MO. Application Deadline This position is anticipated to close on Jun 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.