QA Specialist
Listed on 2026-01-02
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Quality Assurance - QA/QC
Quality Control / Manager, Quality Technician/ Inspector
Job Title:
QA Specialist
We are seeking a detail-oriented and experienced Quality Assurance Specialist to support our quality manufacturing operations. This critical role ensures compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal quality standards. The successful candidate will be responsible for product release, batch record review, and document control, maintaining the integrity of our quality systems.
Responsibilities- Ensure compliance with cGMP, FDA regulations, and internal quality standards.
- Review and approve product release processes.
- Conduct thorough batch record reviews to ensure accuracy and compliance.
- Manage document control systems effectively.
- Play a key role in maintaining and enhancing the quality systems.
- Support CAPA and audit processes to ensure quality assurance.
- Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field, or additional years of experience in lieu of a degree.
- 5 years of experience in pharmaceutical QA, preferably in API manufacturing.
- Strong knowledge of cGMP, FDA regulations (21 CFR Part 211), and ICH guidelines.
- Experience with batch record review and document control systems.
- Proficiency in Microsoft Office and electronic quality management systems (eQMS).
Skills & Qualifications
- Experience in a mix of pharmaceutical and food industry QA is beneficial.
The position involves working in both an office setting and a manufacturing environment as needed to review processes and meet quality requirements.
Job Type & LocationThis is a Contract position based out of St. Francis, WI.
Pay and BenefitsThe pay range for this position is $30.00 – $35.00/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.
- 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 fully onsite position in St. Francis, WI.
Final date to receive applicationsThis position is anticipated to close on Dec 5, 2025.
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