QA Specialist-Manufacturing

Diversified Sourcing Solutions; Alabama; On-site; USD 39,000 - 41,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Documentation

Attention to detail

Independently work

Education

Bachelor's degree (flexible field)

Tools

MS Office

eQMS

Job description

Job Description

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.

Responsibilities

• 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.

Qualifications

• 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

Company Description

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