Quality Assurance Specialist

Job Description

Job Summary:

• The Quality Assurance Coordinator is involved in batch record review, ensures manufacturing records are complete, accurate, and compliant, and identifies any non-conformances and participates in CAPA (Corrective and Preventive Action) activities including deviation investigations.

Key Responsibilities:

1. Batch Record Review:

• Reviews executed batch records, master batch records, and other relevant documentation.
• Ensures records are complete, accurate, and compliant with Good Manufacturing Practices (GMP) and regulatory requirements.
• Identifies potential deviations or non-conformances during the review process.

2. Quality Assurance Support:

• Provides ongoing quality assurance support for manufacturing processes and critical utilities.
• Participates in the development and implementation of quality assurance programs and procedures.
• Conducts assessments, gathering information through interviews, flow charting, and other techniques.

3. Documentation:

• Reviewing and approving QA-driven documentation, such as Standard Operating Procedures (SOPs) and work instructions.
• Maintaining and updating records and documentation.

4. Other Duties:

• Overseeing review and audit of various reports.
• Writing, reviewing, analyzing, and revising SOPs.

Education:

• High School Diploma Required.

Skills and Qualifications:

• Strong understanding of GMP and regulatory requirements.
• Excellent attention to detail and analytical skills.
• Ability to identify and resolve quality issues.
• Good communication and interpersonal skills.
• Knowledge of relevant manufacturing processes and technologies.
• Experience with batch record review and quality assurance activities.