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QA Associate
Career Insights for Quality Assurance Specialist
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What they do
A Quality Assurance Specialist specializes in the prevention of faults in manufactured products and solutions.
$63,046 / year median in Missouri
+1% projected growth
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 2 years of experience in a Quality/GMP environment, with at least 2 years directly in a QA role. 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. Job Type & Location This is a Contract position based out of Bridgeton, MO. Pay and Benefits 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) Workplace Type This is a hybrid position in Bridgeton,MO.