Job Description

Quality Assurance Batch Record Reviewer Newtown, PA

Responsible for performing tasks to specifications related to oral solid and liquid dose pharmaceutical packaging. Processes include reviewing of batch records for the packaging department. Author the Quality Assurance related procedures and process them through Master Control. When required, provide assistance in deviation related activity.

• Key duties and Responsibilities Review the completed batch records for packaging.
• Serve as backup for review of packaging documents when required.
• Ensure the batch records have the proper signature, documentation and completed entries.
• Review to ensure accurate completion of equipment logs.
• Ensure all batch records are accounted for and transferred to the QA department.
• Ensure all entries are entered into the computer system.
• Identify and report quality issues to management.
• Report accidents, unsafe conditions or unusual circumstances to supervisor.
• Adhere to all relevant cGMP and FDA regulations.
• Maintaining a neat and orderly work area at all times
• Provide a support to Investigation team as and when needed.
• Other duties, which may be assigned from time to time, by management of the company
• Comply with FDA guidelines/Company Policies of Data Integrity
• Prepare, review and approve Standard Operating Procedures in Master Control.
• Education and Experience High school diploma or equivalent preferred
• 1+ year of previous experience in a similar position
• Ability to read and comprehend documents such as batch records, packaging instructions, SOPs and training materials.
• Proficient communication skills, both verbal and written.
• Computer experience with basic programs preferred.

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