Title: Pharmaceutical External Auditor Location: Bridgeton, MO, United States category Laboratory & Sciences 90000 USD - 120000 USD/year Job Description: Job Title: Quality Assurance Engineer Job Description We are seeking a Quality Assurance Engineer to join our Quality Assurance team. The role involves conducting all external functions for Quality Assurance, including assessing Contract Manufacturing Organizations' compliance with cGMPs, reviewing Batch Records, Change Controls, applicable regulations, and company policies. The position also provides Quality Assurance oversight for material suppliers, service providers, and contract laboratories as required. The role requires periodic domestic and international travel; a valid passport is necessary. Responsibilities - Ensure suppliers meet industry and company standards set by regulatory agencies and internal SOPs. - Perform supplier qualification as per established policies, ensuring compliance with all regulatory requirements for applicable government agencies. - Assist in the development and maintenance of audit schedules and conduct audits as needed. - Review and approve manufacturing and laboratory deviations, batch documentation, Out-of-Specification, Out-of-Trend, and change requests from suppliers. - Trend performance metrics for suppliers and report regularly to identify potential shifts in supplier performance before supply is impacted. - Track post-audit improvement actions and report regularly on implementation progress. - Perform effectiveness audits of the implemented improvement actions. - Identify and present evidence of quality and compliance risks to QA Management, including Quality Agreements, registration batches, stability, Process Validation, and product launches. - Assist with the management of Supplier Corrective Action Requests related to third-party products. - Support CMO/CPO changes, review batch records, and validation reviews, and generate supplier metrics, presenting in quality system management reviews. Essential Skills - Quality assurance - GMP - Audit - Internal audit - Batch record review - Quality auditing Additional Skills & Qualifications - BS Degree in Sciences or related field or equivalent combination of experience. - 5+ years of pharmaceutical QA in a GMP manufacturing environment; 10+ years of experience preferred. - Specific experience with external/supplier auditing. - Thorough experience in Batch Record Review including all associated documentation for release. - Experience auditing a variety of facilities is ideal (aseptic, packaging, lab, component/ingredient suppliers, etc.). - Willingness to travel internationally 1-2 times/year with a valid passport. - Willingness to travel domestically for audits 3-4 times/year. Work Environment The position is based in a QA cubicle area inside an office building connected to the manufacturing facility. There is no expectation to enter the manufacturing area. The work schedule is Monday through Friday from 8:00 to 4:30, with some flexibility in start and end times. There is potential for remote/hybrid work after the initial training period. The role involves collaboration with a team of five other QA Engineers and the Manager, as well as external partners and internal teams such as Sourcing/Supply Chain, QA, and QC. 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 (6% Match), PTO (13 company holidays, 5 floating holidays, 15 vacation days, 5 personal days), Health, Medical, Dental, Vision, Bonus program, pet insurance Workplace Type This is a fully onsite position in Bridgeton,MO. 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.