QA Engineer

The Quality Assurance Engineer – External will provide comprehensive quality oversight of external partners, including Contract Manufacturing Organizations (CMOs), material suppliers, service providers, and contract laboratories. This role focuses on ensuring compliance with cGMPs, applicable regulations, internal policies, and quality agreements by performing supplier audits, reviewing batch records and associated documentation, and monitoring supplier performance. The position involves close collaboration with internal cross-functional teams and external partners, as well as periodic domestic and international travel to support audits and quality activities.

Responsibilities

• Assess Contract Manufacturing Organizations (CMOs) and other external partners for compliance with cGMPs, applicable regulations, and internal company policies.
• Ensure suppliers meet industry and internal standards established by regulatory agencies and internal standard operating procedures (SOPs).
• Ensure supplier qualification activities are performed according to established policies and meet all regulatory requirements for applicable government agencies.
• Assist in the development and maintenance of supplier audit schedules and perform external audits as needed.
• Review and approve manufacturing and laboratory deviations, batch documentation, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, 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 provide regular reports to identify potential shifts in supplier performance before supply is impacted.
• Track post-audit improvement and corrective actions, and report regularly on implementation progress.
• Perform effectiveness audits of implemented improvement actions to verify that corrective and preventive actions address the identified issues.
• Identify quality and compliance risks related to external partners and present clear evidence and recommendations to Quality Assurance management.
• Provide quality oversight related to Quality Agreements (QAAs), registration batches, stability studies, Process Validation (PV), and product launches involving external partners.
• Assist with the management of Supplier Corrective Action Requests (SCARs) for third-party products under quality oversight.
• Support CMO and Contract Packaging Organization (CPO) changes, including review of batch records and validation documentation.
• Generate and maintain supplier quality metrics and present results in quality system management reviews.
• Collaborate closely with internal teams such as Sourcing/Supply Chain, QA, QC, and other stakeholders to ensure alignment on quality expectations and issue resolution.
• Communicate effectively with external partners to clarify quality requirements, follow up on audit findings, and drive continuous improvement.

• 5+ years of pharmaceutical Quality Assurance experience in a GMP manufacturing environment; 10+ years of experience preferred.
• Specific experience with external and supplier auditing in a pharmaceutical or GMP-regulated environment.
• Thorough experience in batch record review, including all associated documentation for product release such as deviations, change controls, and validation documentation.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
• Demonstrated experience in quality auditing, including planning, conducting, and reporting on audits.
• Ability to assess and interpret quality and compliance risks related to suppliers and external partners.
• Strong analytical skills to trend supplier performance metrics and identify potential issues proactively.
• Ability to manage Supplier Corrective Action Requests (SCARs) and verify effectiveness of corrective actions.
• Excellent written and verbal communication skills for interaction with internal teams and external partners.
• Ability and willingness to travel internationally 1–2 times per year with a valid passport.
• Ability and willingness to travel domestically for audits approximately 3–4 times per year.

• BS degree in a scientific discipline or related field, or an equivalent combination of education and experience.
• Experience auditing a variety of facilities, such as aseptic manufacturing, packaging sites, laboratories, and component or ingredient suppliers.
• Experience working with Quality Agreements (QAAs), registration batches, stability programs, Process Validation (PV), and product launches.
• Familiarity with managing and maintaining supplier audit schedules and quality metrics.
• Ability to work effectively within a cross-functional team environment and build strong relationships with external partners.
• Strong organizational skills with the ability to manage multiple audits, reviews, and follow-up activities concurrently.
• Proficiency in documenting audit findings, deviations, and change controls in a clear and compliant manner.

The role is based in a Quality Assurance cubicle area within an office building that is connected to a manufacturing facility. The position is office-based and is not expected to enter the manufacturing area. The standard schedule is Monday through Friday, typically 8:00 a.m. to 4:30 p.m., with some flexibility on start and end times. After an initial training period of approximately three months, and depending on contract extension, the role may offer the option of working remotely one day per week. The Quality Assurance Engineer will work as part of a close-knit team of five other QA Engineers and a QA Manager, collaborating frequently with internal functions such as Sourcing/Supply Chain, QA, and QC, as well as with external partners including CMOs, suppliers, service providers, and contract laboratories. The environment emphasizes teamwork, clear communication, and strong quality culture, with regular interaction and coordination to support audits, supplier oversight, and continuous improvement in quality systems.

Job Type & Location

This is a Permanent position based out of Bridgeton, MO.

The pay range for this position is $90000.00 - $105000.00/yr.

401K match (6%), 15 vacation days, 5 personal days, 5 floating holidays, and 13 paid/named holidays. There are also benefits for pet insurance, standard medical/dental/vision, etc.

This is a fully onsite position in Bridgeton,MO.

This position is anticipated to close on Apr 22, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.