Responsibilities:
- Responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.
- MES/SAP/LIMS Super User to include floor support and training.
- SPOC for Batch Record Process includes creating reports; production terminating and approving records; issue resolution.
- Reviews all batch documentation for accuracy and completeness according to cGMP's to ensure timely release.
- Ensures deviations are initiated for any batch record review related events Find/communicate deviations to QA /help with investigation
- Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
- Ensures all GMP's, Work Procedures and SOP's are followed.
- Positively interacts with internal associates to quickly and effectively resolve batch record documentation related issues.
- Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and Client objectives.
- Within MES, is responsible for TECO all Manufacturing orders.
- Provide periodic updates at Manufacturing Team meetings to review current batch record errors to improve performance.
- Maintains strong collaborative relations with the Quality Group
- Maintain and follow CGTDM procedures for MBR creation, issuance, receipt, reconciliation, filing and archiving
- Print and issue batch records, in-process labels, and final product labels to support operations.
- Issue labeling/tags for Apheresis through packaging of final product labelling to QA/Operations.
Education:
- BS degree or equivalent pharmaceutical experience. Strong background in Good Documentation Practices (GDP)
Experience:
- 1 -3 years experience in a regulated cGMP Environment. Strong aseptic manufacturing knowledge preferred
Other Qualifications:
- Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required
- Must be well organized, flexible and work with minimal supervision
- Alternate shifts, weekends and overtime will be required
Job Type: Contract
Pay: $40.00 per hour
Work Location: In person