Quality Assurance Associate, Batch Release

Cook Medical; Pittsburgh (Allegheny County); On-site; USD 60,000 - 90,000; Full time

Job summary

Cook MyoSite, Inc., part of the Cook Group, is seeking a Quality Assurance Associate to perform detailed quality reviews of batch records and ensure compliance with regulatory requirements.

You will review documentation for tissue procurements, approve records, support cGMP operations, and participate in inspections while upholding CookMyoSite Core Values.

Qualifications

• Associates degree in Life Sciences, Biomedical or related fields or 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) andcGMPs

Responsibilities

• Perform quality review of prepared material, cell therapy intermediate and final product batch records, and associated records.
• Review and approve documentation associated withinincoming 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 CookMyoSiteCore Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• Trainability
• Strong interpersonal skills resulting inexceptionalrapport 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

Interpersonal skills

Trainability

Education

Associates degree in Life Sciences/Biomedical or related fields

Tools

Microsoft Office

Job description

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Quality Assurance Associate will perform detailed quality reviews of batch records and associated records while ensuring compliance with procedural and regulatory requirements.

Responsibilities

• Perform quality review of prepared material, cell therapy intermediate and final product batch records, and associated records.
• Review and approvedocumentation associated withincoming 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 CookMyoSiteCore 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 inexceptionalrapport 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

Full-Time Onsite

Qualifications

Associates degree in Life Sciences, Biomedical or related fields or 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) andcGMPs

Proficient knowledge of Microsoft Office software, and other general office equipment.

Physical Requirements

Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafetyLevel II.

Lab / Non-Production

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able 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.
• Must be able to sit atdesk, 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 reasonableaccommodations.
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonableaccommodations.
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafetyLevel 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.

Employee that does not interact with Healthcare Professionals

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.

At Cook MyoSite, we don’t just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.

This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.