Quality Assurance Specialist
$58,000–$62,000 year
On-siteGulfport, Mississippi, United States
Job Summary
Review and approve raw materials, packaging components, labeling, and monographs while administering complaint investigations and coordinating recalls. Audit manufacturing processes, handle quarantine shipments, and revise batch records to maintain a cGMP Quality System compliant with 21CFR210 and 21CFR211. Perform investigations, determine root causes, and develop CAPAs to support the Quality Assurance Manager. This role requires a Bachelor's degree in Chemistry or Biology, three years of pharmaceutical quality assurance experience, and expert knowledge of FDA policies. Based in Gulfport, MS, the position offers a salary range of $58,000 to $62,000 with full-time employment status and benefits including health, dental, and vision insurance.
Required Qualifications
- B.S. in Chemistry, Biology, or equivalent work experience in a related field
- Experience in computer software, such as Microsoft applications
- Expert knowledge of cGMP regulations
- Expert knowledge and understanding of FDA policies and regulations
- Pharmaceutical experience required
- Reliably commute or planning to relocate before starting work (Required)
- Bachelor's (Preferred)
- Quality assurance: 3 years
- Pharmaceutical Investigations: 3 years
Desired Qualifications
- Excellent verbal and written communication skills in English
- Excellent management and teamwork skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Ability to function well in a high-paced and at times stressful environment
- Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company
- Understanding of quality systems including change control, deviations and CAPAs
- Ability to handle multiple tasks concurrently and complete them in a timely manner
- Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization
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