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QA Specialist
- Actalent (Ballwin, MO)
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QA Specialist
Job Description
The QA Specialist will support various Quality department duties involved with the release of pharmaceutical products. This role requires a meticulous individual to review completed records, logbooks, and some laboratory and manufacturing notebooks. The specialist will assist in managing the quality documentation system, including routing for signatures, editing, uploading, and filing. Additionally, the QA Specialist will author Standard Operating Procedures (SOPs) and manage stability studies.
Responsibilities
+ Conduct quality assurance reviews of completed records, logbooks, and laboratory and manufacturing notebooks.
+ Assist in managing the quality documentation system, including routing for signatures, editing, uploading, and filing.
+ Author and update Standard Operating Procedures (SOPs).
+ Manage stability studies and participate in quarterly QA audits.
+ Assist in investigations for Out of Specification (OOS), Deviations, and Corrective and Preventive Actions (CAPAs).
+ Contribute to the writing of annual product reports and help with trending analytical and manufacturing data, proposing improvements.
+ Review and release raw materials based on specifications.
+ Support customer and regulatory audits.
Essential Skills
+ Experience in quality assurance and record review.
+ High integrity and transparent communication skills.
+ Ability to collaborate effectively and educate on corrective measures.
+ Experience with CAPA, audit processes, FDA regulations, and document control.
Additional Skills & Qualifications
+ Bachelor's degree preferred but not required.
+ 3-5 years of GMP quality experience, preferably in a pharmaceutical manufacturing environment.
+ Direct experience with record review and release.
Work Environment
The role is based in a brand-new manufacturing and lab space within an existing building. The QA Specialist will primarily work at a desk but may have exposure to manufacturing suites and lab environments. The position operates on a Monday to Friday day shift. The company fosters a growing team with a growth mindset, ideal for those willing to take on additional responsibilities or learn new skills.
Job Type & Location
This is a Contract to Hire position based out of Ballwin, MO.
Pay and Benefits
The pay range for this position is $30.00 - $32.00/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 fully onsite position in Ballwin,MO.
Application Deadline
This position is anticipated to close on Dec 9, 2025.
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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
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