Location: Cherry Hill,NJ, USA
Purpose:
The Batch Records Reviewer ensures that manufacturing batch records, including all associated documentation, comply with cGMP and regulatory requirements. This role is responsible for reviewing batch production records, validating documentation accuracy, and ensuring all deviations and issues are appropriately addressed. The position plays a key role in maintaining the integrity and quality of the production process by ensuring that all documentation is complete and in accordance with regulatory standards.
Responsibilties:
* Batch Record Review:
* Review and approve batch production records for completeness, accuracy, and compliance with company standards and cGMP regulations.
* Ensure that all documentation is accurate and compliant before final batch release
* Deviation Management:
* Identify and document any deviations or discrepancies in the batch records.
* Work with manufacturing and QA teams to investigate deviations and ensure corrective and preventive actions (CAPAs) are implemented.
* Documentation Control:
* Maintain and update batch record review documentation to ensure compliance with regulatory and company standards.
* Ensure that completed batch records are properly archived and readily accessible for retrieval when needed.
* Compliance Assurance:
* Ensure batch records adhere to relevant FDA, EMA, and other regulatory requirements.
* Stay current with regulatory changes and ensure batch records are in compliance with the latest requirements
* Support for Audits:
* Provide batch records and documentation support during internal and external audits.
* Assist in preparing for regulatory inspections by maintaining clear and complete records.
* Training & Continuous Improvement:
* Provide training on batch record review processes and cGMP requirements to production and QA personnel.
* Participate in continuous improvement initiatives within the Quality Assurance department.
* Collaboration & Communication:
* Work closely with cross-functional teams (e.g., Manufacturing, R&D, and Regulatory Affairs) to resolve batch record-related issues.
* Communicate effectively with other departments to address discrepancies or issues identified during batch record review.
* Physical Demands:
* Ability to walk throughout the facility for approximately about 40% of the shift.
* Ability to lift and move documents up to 50 lbs.
* Capable of using a ladder to archive or retrieve documents as needed.
* NOTE: Additional tasks as directed by the supervisor or designee, as needed.
QUALIFICATIONS
* Minimum: Associate's degree in Life Sciences, Pharmacy, or a related field with 2-3 years of relevant experience in batch record review or pharmaceutical manufacturing (QA experience preferred).
Preferred: Bachelor's degree in Life Sciences, Pharmacy, or a related field with 1-2 years of applicable experience in batch record review, pharmaceutical manufacturing, or a related quality assurance role.
EXPERIENCE
* Minimum: 1-3 years of experience in a pharmaceutical or manufacturing environment, specifically related to quality assurance or batch record review.
Preferred: Experience in batch record review, deviation management, and cGMP-compliant documentation in the pharmaceutical industry.
SKILLS
* Technical Proficiency: Strong knowledge of cGMP regulations, FDA regulations, and industry standards (e.g., CFR, EU regulations).
* Attention to Detail: Exceptional ability to identify and address discrepancies, errors, or gaps in documentation.
* Organizational Skills: Ability to manage multiple tasks simultaneously and prioritize effectively in a fast-paced environment.
* Problem-Solving: Strong analytical skills to identify root causes of discrepancies and propose corrective actions.
* Communication Skills: Excellent written and verbal communication skills to collaborate with cross-functional teams and report issues effectively.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia