Job at a glance
QA Specialist Job Description Supports all quality system elements to assure compliance with FDA cGMP and other quality standards, with primary responsibilities in Supplier Quality. Responsibilities Manage supplier qualification activities for new and existing suppliers. Coordinate supplier onboarding through questionnaires, quality agreements, paper audits, and supporting documentation. Review, process, and support supplier-related Change Controls.
Assess supplier quality documentation to ensure compliance with internal quality requirements and regulatory expectations. Support qualification of suppliers providing APIs, raw materials, components, packaging materials, bottles, pails, bags, contract manufacturing services (CMOs), and external laboratory services. Track and manage supplier qualification projects from initiation through approval.
Communicate directly with suppliers regarding qualification requirements, documentation requests, and quality-related inquiries. Support supplier risk assessments and supplier quality evaluations. Participate in supplier audit preparation and follow-up activities, including documentation review and paper-based audits. Maintain supplier qualification records and ensure documentation is complete and audit-ready.
Collaborate with internal stakeholders to resolve supplier quality issues and support continuous improvement initiatives. Assist with Annual Product Reviews (APRs) and related quality documentation when applicable. Essential Skills Quality assurance and regulatory expertise. 3+ years of experience in a FDA regulated pharmaceutical facility is preferred. 3+ years of experience in Quality Assurance / Quality Systems.
Exposure and experience with Quality Systems, preferably Supplier Quality, Change Control, Label Control, and Annual Product Reviews. Experience in pharmaceutical industry, Audit, Regulatory submission, Regulatory affairs, and Quality management. Additional Skills & Qualifications Bachelor’s degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred. Strong experience in supplier qualification, including knowledge and experience with supplier qualification questionnaires, quality agreements, change controls, paper-based audits, supplier documentation, and qualification requirements.
Proficient in the use of MS Office tools (Word, Excel, Outlook). Good verbal, written, and electronic communication skills to work back and forth with suppliers. Work Environment The position requires working onsite from Monday to Friday, 8:00 AM - 4:30 PM or a similar variation. Job Type & Location This is a Contract to Hire position based out of St. Louis, MO. Pay and Benefits The pay range for this position is $26.44 - $31.25/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 St.
Louis,MO. Application Deadline This position is anticipated to close on Sep 17, 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 initiativ