09/25/2024
Job Title: Batch Record Reviewer
Location: Maryland
Start Date: Monday, September 30, 2024
Employment Type: Contract
Duration: 6 months (with potential for extension)
Industry: Pharmaceutical/Biotech Manufacturing
Total Openings: 5
Email: [email protected]
Job Summary:
We are seeking 5 Batch Record Reviewers for a leading pharmaceutical client in Maryland. The role involves reviewing batch records to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal standards. The reviewers will work closely with Quality Assurance, Production, and Compliance teams to maintain high standards of product quality.
Key Responsibilities:
Conduct thorough review of batch production and packaging records for accuracy and completeness.
Ensure batch records comply with cGMP, SOPs, and FDA regulations.
Identify and document discrepancies, deviations, and non-conformance in batch records.
Collaborate with Production and Quality Assurance teams to resolve any issues found in documentation.
Maintain organized records and ensure timely completion of documentation to meet production schedules.
Participate in investigations related to product quality and assist with CAPA (Corrective and Preventive Actions).
Support audits and inspections as required.
Qualifications:
Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field preferred.
2+ years of experience in batch record review within the pharmaceutical, biotech, or life sciences industry.
Strong knowledge of cGMP, FDA regulations, and industry best practices.
Excellent attention to detail with the ability to identify errors and inconsistencies.
Strong written and verbal communication skills.
Ability to work in a fast-paced environment and meet tight deadlines.
Proficiency in Microsoft Office and documentation systems.
Preferred Qualifications:
Previous experience working in aseptic or sterile production environments.
Experience with electronic batch record (EBR) systems.
Benefits:
Competitive hourly rate.
Opportunity to work with a leading pharmaceutical company.
Potential for contract extension based on performance and project needs.
hashtag to Apply:
Interested candidates should comment "Interested" and immediately send their resume to [email protected] with the subject line “Batch Record Reviewer – Maryland.”
hashtag : Please do not apply if you are associated with any employer, as this position is not open for C2C arrangements.
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