Sr QA Specialist - I*

Sr QA Specialist - I* Job ID: 24-03368 NOTE: Position is Day Shift including weekends and requires onsite presence.

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, etc.

• 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

Basic Qualifications

Master's Degree and 5+ years of experience in GMP environment OR

Bachelor's Degree and 7+ years of experience in GMP environment OR

High School Degree and 11+ years of experience in GMP environment

Preferred 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

• Good interpersonal skills

• Strong written communication skills

• Strong analytical skills

• Comfortable in a fast-paced small company environment and operate with minimal direction

• Ability to adjust workload based upon rapidly changing priorities

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