Quality Assurance Specialist

3 months ago

Severn, United States LanceSoft, Inc. Full time

Job Title – QA Batch Record Reviewer

Location – 7555 Harmans Rd, Harmans, MD 21077

Duration : 3 months contract possibly extension

Pay Range : $40.00 - $45.00 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.

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