Quality Assurance Specialist – GMP, CAPA & Batch Records

Diversified Sourcing Solutions; Alabama; Vor Ort; USD 39.000 - 41.000; Vollzeit

Zusammenfassung

Diversified Sourcing Solutions is seeking an experienced Quality Assurance Specialist to join our pharmaceutical manufacturing team. This role emphasizes rigorous documentation, GMP/cGMP compliance, deviations, and CAPA processes in an FDA-regulated environment.

Responsibilities include reviewing batch records, supporting deviation investigations, maintaining CAPA documentation, and ensuring real-time quality records with robust document control.

Qualifikationen

• Bachelor's degree required (field flexible).
• 3–4 years of QA experience in FDA-regulated environment.
• Hands-on experience with deviation investigations and CAPA processes.
• Strong knowledge of GMP/cGMP regulations and FDA compliance.
• Experience reviewing batch records and controlled documentation.
• Proficiency with MS Office and electronic quality/document management systems (eQMS preferred).
• Excellent attention to detail, organization, and documentation skills.

Aufgaben

• Review batch records and production documentation for accuracy, completeness, and GMP compliance.
• Participate in deviation investigations and documentation.
• Support and maintain CAPA activities, including corrective and preventive action documentation.
• Review manufacturing records and quality documentation to ensure compliance with company procedures and FDA regulations.
• Assist with document control, change control, and records management.
• Maintain quality documentation within electronic document management systems.
• Provide QA support to manufacturing teams and help ensure documentation is completed correctly and in real time.
• Maintain accurate quality records and support regulatory compliance initiatives.

Kenntnisse

Quality Assurance

Documentation

Attention to detail

Independently work

Ausbildung

Bachelor's degree (flexible field)

Tools

MS Office

eQMS

Jobbeschreibung

Diversified Sourcing Solutions is seeking an experienced Quality Assurance Specialist to join our pharmaceutical manufacturing team. This role emphasizes rigorous documentation, GMP/cGMP compliance, deviations, and CAPA processes in an FDA-regulated environment.

Responsibilities include reviewing batch records, supporting deviation investigations, maintaining CAPA documentation, and ensuring real-time quality records with robust document control.