Cell Therapy QA Specialist, cGMP Compliance

Cook Medical; Pittsburgh (Allegheny County); On-site; USD 60,000 - 80,000; Full time

Job summary

Cook MyoSite, a member of Cook Group, is seeking a Quality Assurance Associate to perform detailed quality reviews of batch records and ensure regulatory compliance in a cGMP environment. You will review documentation for tissue procurements, create batch records, support inspections, and contribute to continuous improvement.

This onsite role requires an Associates degree in Life Sciences or equivalent CGMP experience.

Qualifications

• Associates degree in Life Sciences or 4 years of relevant cGMP experience.
• Knowledge of FDA regulations (21 CFR 210/211) and cGMPs.
• Proficient in Microsoft Office and general office equipment.

Responsibilities

• Perform quality review of batch records and associated records.
• Review and approve documentation for tissue procurements and materials.
• Review and approve records and associated data in support of cGMP operation activities.
• Create, distribute, and reconcile batch records and labels.
• Lead and facilitate the authoring of production‑related investigation records.
• Support Supply Chain activities, including oversight and verification of product shipment.
• Review and approve documentation supporting Custom Cells Solutions manufacturing.
• Conduct and document training events.
• Participate in self‑led inspections and provide support during internal/external regulatory inspections.
• Identify and participate in continuous improvement opportunities; support inspection readiness.
• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• 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

Skills

Verbal communication

Written communication

Interpersonal skills

Attention to detail

Time management

Trainability

Problem solving

Education

Associate degree in Life Sciences

Tools

Microsoft Office

Job description

Cook MyoSite, a member of Cook Group, is seeking a Quality Assurance Associate to perform detailed quality reviews of batch records and ensure regulatory compliance in a cGMP environment. You will review documentation for tissue procurements, create batch records, support inspections, and contribute to continuous improvement.

This onsite role requires an Associates degree in Life Sciences or equivalent CGMP experience.