On-Site QA Supervisor - cGMP Compliance Lead (1st Shift)

Scientific Protein Laboratories, LLC; Alabama; Sur place; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Excellent benefits: Medical, Dental, V

Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health and Flexible Saving Account

Employee Assistance Program

Generous vacation

Paid Holidays

401k

Advancement opportunities

Team-oriented environment

Community involvement

Company events

Résumé du poste

Scientific Protein Laboratories, LLC outside Madison, Wisconsin is seeking an On-Site QA Supervisor to oversee the QA staff, manage batch record reviews, and ensure cGMP compliance across operations. The role emphasizes inspections, material release, CAPAs, and continuous improvement.

The ideal candidate has 5+ years in pharmaceutical QA, with leadership experience and a track record of coordinating deviations, investigations, and audits.

Qualifications

• 5 years’ experience; 10+ years preferred in Pharmaceutical Quality Assurance.
• Experience leading QA professionals in manufacturing/testing areas.
• Experience preparing for Annual Product Reviews.
• Experience coordinating deviations, investigations, change controls and CAPAs.
• Experience performing all Quality Assurance functions and creating continuous improvement in those functions.

Responsabilités

• Oversee on-site QA staff and release of raw materials.
• Organize establishment/maintenance of relevant procedures/documents.
• Assists all departments in the identification and evaluation of facility events.
• Determine disposition of packaging materials, in-process materials and products on the basis of approved specifications.
• Participates in the preparation of Annual Product Review documentation for all SPL Marketed Products.
• Provide appropriate data and QA support for SPL regulatory functions.
• Coordinates/reviews deviations, investigations, change controls and CAPAs
• Participates in audits and addresses audit findings where necessary.
• Performs intermediate product release and finished product release assessments.
• Product shipping release.
• Responsible for continuous improvement of SPL cGMP Quality Systems to support on-site QA in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
• Compiles and communicates metrics associated with on-site QA to management as required.

Connaissances

QA supervision

Team leadership

cGMP

FDA/ICH compliance

Batch record review

Raw material inspection

Audits

Description du poste

Scientific Protein Laboratories, LLC outside Madison, Wisconsin is seeking an On-Site QA Supervisor to oversee the QA staff, manage batch record reviews, and ensure cGMP compliance across operations. The role emphasizes inspections, material release, CAPAs, and continuous improvement.

The ideal candidate has 5+ years in pharmaceutical QA, with leadership experience and a track record of coordinating deviations, investigations, and audits.