QA Specialist-Manufacturing

Job Overview:
We are seeking an experienced Quality Assurance Specialist to join a pharmaceutical manufacturing team. This is a documentation-heavy role that requires experience working in an FDA-regulated environment with a strong understanding of GMP compliance, deviations, and CAPA processes.

• 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.

• Bachelor's degree required (field of study is flexible).
• 3–4 years of Quality Assurance experience in a pharmaceutical, biotechnology, medical device, or other FDA-regulated manufacturing environment.
• Hands-on experience with deviation investigations and CAPA processes is required.
• Strong knowledge of GMP/cGMP regulations and FDA compliance.
• Experience reviewing batch records and controlled documentation.
• Proficiency with Microsoft Office and electronic quality/document management systems (eQMS preferred).
• Excellent attention to detail, organization, and documentation skills.
• Ability to work independently in a fast-paced manufacturing environment.

Compensation: $28-$30/hr

Diversified Sourcing Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics

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