Job Title – QA Batch Record Reviewer
Location – 7555 Harmans Rd, Harmans, MD 21077
Duration : 3 months contract possibly extension
Pay Range : $30.00 - $35.00 USD hourly on W2
Responsibilities
- Perform Product Disposition and Lot Closure. Includes commercial and clinical products.
- Review batch-related documentation and ensure resolution of issues to release product.
- Review batch-related shipment documentation to ensure product shipment remained in control.
- Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
- Provide QA oversight and (limited) approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
- Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved.
- Support and participate in investigations, including batch record review.
- Ensure process control measures are in place and followed in product manufacturing.
- Maintain metrics related to product disposition in support of the Management Review.
- Generate and update procedures, forms and other documents.
- As assigned, manage and provide QA oversight for other processes, including training, warehouse/inventory, redose, new product introductions.
- Generate and report data for management.
- Maintain production (finite), disposition, and team schedules.
- Represent Disposition or QA Ops at plant and multi-site scheduling meetings.
- Provide QA representation on projects and at team meetings.
- Provide QA representation at multi-site disposition meetings.
- Support and participate in inspections and audits.
Qualifications:
- Bachelor’s degree in the biological sciences or related field and minimum of 7 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
- Ability to interpret and apply procedural and regulatory guidance in potentially ambiguous situations.
- Ability to understand risk and provide phase-appropriate appropriate decisions.
- Ability to effectively negotiate and build collaboration amongst individuals.
