Quality Assurance Associate, Batch Release
On-sitePittsburgh, Pennsylvania, United States
Job Summary
Conduct detailed quality reviews of batch records, cell therapy materials, and cGMP documentation while approving records for incoming tissue procurements and Custom Cells Solutions manufacturing. Create, distribute, and reconcile batch records and labels, lead authoring of investigation records, and support supply chain verification for product shipments. Facilitate training events, participate in self-led and external regulatory inspections, and identify continuous improvement opportunities to maintain inspection readiness. Perform duties in a laboratory setting with potential exposure to hazardous chemicals, requiring extended hours including evenings and weekends as needed.
Required Qualifications
- Associates degree in Life Sciences, Biomedical or related fields
- 4 years of direct, relevant experience in cGMP environment to provide a comparable background
- Minimum of 1-3 years' experience in cGMP background
- Knowledge and application of industry standards and guidelines/regulations related to the manufacturing of sterile injectable drug and biologic products (21 CFR 210 and 211) and cGMPs
- Proficient knowledge of Microsoft Office software
- Ability to conduct and hear ordinary conversation and telephone communication
- Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
- Ability to work under specific time constraints
- Ability to sit at desk, in meetings and/or work on a computer for long or extended periods of time
- Visual and manual acuity for working with computers and equipment
- Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting
- Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
- Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations
- Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis
- Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time
- Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations
Desired Qualifications
- Ability to work in collaborative and independent work situations and environments with minimal supervision
- Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
- Trainability
- Must have effective verbal, written and interpersonal skills
- Able to prioritize and operate proactively
- Must exhibit well developed skills in prioritizing, planning, organization, decision making, and time management
- Must maintain a high level of confidentiality
- Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations
- Demonstrates critical thinking and ability to execute goals set by the organization and Department Manager
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