Batch Record Reviewer and Investigator

Contract: 6+ months

Location: Edmond, OK - Hybrid

The Batch Record Reviewer & Investigator is responsible for providing support and guidance to manufacturing for GMP documentation of finished drug product. Responsibilities include but are not limited to GMP documentation review and mentoring the client’s staff. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards and to train quality assurance staff on best practices.

The Job Role Summary:

· Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents.

· Support the evaluation and lot disposition of drug product.

· Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs.

· Contributes to process improvement of batch records and associated processes (e.g., turnaround times) to ensure all QA batch disposition deadlines are met.

· Assist with deviations and CAPA resolution.

· Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices.

· Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.

· Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs.

· Participate in site and corporate quality and process improvement initiatives.

Education and Experience Requirements:

· B.S., Life Sciences discipline preferred

· +10 years’ experience within the biologic, biopharmaceutical, pharmaceutical or regulated industry

· +5 years’ experience in a Quality Assurance/Quality Control or Manufacturing function

· Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines

Job Types: Full-time, Contract

Pay: $95.00 - $130.32 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Quality assurance: 5 years (Required)
• biopharmaceutical, pharmaceutical or regulated industry: 8 years (Required)

Work Location: Hybrid remote in Edmond, OK 73013

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