QA Associate

Job Description

Job Description

Job Title: QA Associate

Job Description

The Quality Assurance (QA) Associate supports clinical and commercial manufacturing operations by reviewing and managing documentation for registration and clinical batches. This role ensures compliance with FDA and other regulatory requirements, supports R&D and feasibility projects, and contributes to continuous improvement in quality and compliance. The QA Associate works independently on smaller projects, collaborates closely with cross-functional teams, and maintains high standards of accuracy, accountability, and attention to detail.

Responsibilities

• Review and interpret batch records, manufacturing protocols, and registration/clinical batch documentation to ensure completeness, accuracy, and compliance.
• Verify that all documentation aligns with FDA regulations and other applicable regulatory agency requirements.
• Review and manage deviations, change controls, and CAPAs, ensuring they are properly documented, justified, and closed in a timely manner.
• Evaluate method validation and equipment qualification protocols and reports for accuracy, clarity, and compliance with GMP and regulatory expectations.
• Confirm that standard operating procedures (SOPs) are followed and that all associated documentation is complete, accurate, and properly maintained.
• Provide constructive feedback on validation documents and recommend improvements to better align with regulatory and quality standards.
• Conduct document reviews for batch records, equipment records, validation records, and related quality documentation in commercial and development settings.
• Support clinical batch compliance activities, including walking through scale-up production environments and, as needed, visiting operations areas for final checks.
• Collaborate closely with internal R&D and manufacturing teams to resolve documentation issues and support ongoing projects.
• Occasionally assist with CDMO-related quality tasks in coordination with internal leadership.
• Prioritize multiple document review and protocol review activities to meet project timelines and quality objectives.
• Demonstrate initiative by seeking additional work, asking questions when clarification is needed, and proactively addressing potential quality concerns.
• Contribute to team efforts to improve overall compliance and strengthen quality systems across R&D and manufacturing.

Essential Skills

• Minimum of 1 year of experience in a Quality/GMP environment, with at least 2 years directly in a QA role preferred.
• Hands-on experience reviewing batch records in a commercial or development setting.
• Practical experience reviewing supporting documents such as deviations, change controls, CAPAs, and related GMP documentation.
• Demonstrated ability to assess documentation for compliance with GMP standards and regulatory requirements.
• Strong quality assurance background with specific experience in batch record review and document control.
• Solid understanding of manufacturing protocols, equipment records, and validation records.
• Experience working in or with pharmaceutical environments, strongly preferred.
• High level of attention to detail and accuracy in documentation review.
• Ability to prioritize workload and manage multiple document and protocol reviews effectively.
• Strong sense of responsibility and accountability for quality outcomes.
• Collaborative working style with the ability to partner effectively with cross-functional teams.
• Initiative to seek clarification, request additional work, and contribute to process improvements.

Additional Skills & Qualifications

• AS or BS degree preferred; high school diploma required.
• Broad, well-rounded experience reviewing GMP documentation across batch records, equipment records, validation records, and related quality documents.
• Familiarity with pharmaceutical manufacturing processes and R&D environments.
• Ability to understand and provide feedback on method validation and equipment qualification protocols and reports.
• Strong organizational skills for managing documentation and maintaining compliance records.
• Effective communication skills for collaborating with R&D, operations, and other internal teams.
• Interest in developing a well-rounded QA skill set across clinical, commercial, and R&D activities.
• Comfort working independently on smaller projects while also engaging in cross-functional collaboration.

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

The pay range for this position is $24.00 - $24.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Bridgeton,MO.

This position is anticipated to close on Jul 29, 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 View email address on ziprecruiter.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.