Quality Assurance Associate, Batch Release

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. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose.

Responsibilities

• Perform quality review of prepared material, cell therapy intermediate and final product batch records, and associated records.
• Review and approve documentation associated with incoming 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.
• Exemplify Cook MyoSite Core Values.
• Maintain regular and punctual attendance.
• Must maintain company quality and safety standards.
• Work in collaborative and independent work situations and environments with minimal supervision.
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability.
• Work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals.

Requirements

• 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) and cGMPs.
• Proficient knowledge of Microsoft Office software and other general office equipment.
• Effective verbal, written, and interpersonal skills.
• Able to prioritize and operate proactively.
• Well-developed skills in prioritizing, planning, organization, decision making, and time management.
• 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.
• Ongoing commitment to upgrading knowledge, job skills, and abilities.

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 BioSafety Level II.
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule, including evenings, weekends, and extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings, and/or work on a computer for extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Ability to spend the majority of the day standing in a laboratory setting or sitting in a 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 frequently 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.

Schedule

Full-Time Onsite