Quality Assurance Facility, Systems and Equipment Specialist

Posting Date 2 weeks ago(11/10/2020 9:14 AM)
Requisition ID
Job Location(s)
Pittsburgh PA United States
Position Type
Full Time
Cook Myosite Inc.


Cook MyoSite, Inc. 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 Facility, Systems, and Equipment Specialist at Cook Myosite will review and facilitate approval of all Quality System documentation pertaining to Facility, Systems, and Equipment Functions.


• Understand, interpret, and apply regulatory requirements pertaining to facilities, equipment, and utilities in an FDA-regulated environment
• Function as a quality subject matter expert in the areas of facility, utilities, and equipment, as a quality representative in these areas on project teams, and be able to respond to auditors’ and inspectors’ questions
• Review and approve/reject the design and validation of facilities, equipment, and utilities within the organization to ensure the systems planned and qualified/validated in a compliant manner that is consistent with their intended use
• Facilitate authoring of investigations, especially those pertaining to facility and equipment deviations, and assist in identification of appropriate CAPAs to address problems

• Review and approve/reject, facility, equipment and utility change controls/requests, SOPs, maintenance and calibration reports, and facility records such as pest control reports, to ensure all are maintained in a compliant manner, in accordance with their intended use
• Review and approve prepared material, intermediate, and final product batch records, and disposition accordingly
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards

• Perform additional activities related to overall Quality Assurance as requested by management, e.g. audits, vendor qualifications.

• Promote GLP/cGMP environment and follows procedural guidelines.


• Undergraduate degree in any Life Science or related Engineering field and 1-3 years’ experience in pharmaceutical/biopharmaceutical industry or 6 years direct, relevant experience in pharmaceutical/biopharmaceutical quality assurance to provide a comparable background

• Minimum of 1-3 years' experience in applying GMP requirements of facilities and equipment and sufficient biology/biochemistry to understand the methodology associated with manufacturing a cell therapy product in an FDA-regulated environment.  

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

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

• Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

• Project management experience or experience as part of a project team or project team leader preferred

• Ability to work in collaborative and independent work situations and environments with minimal supervision

• Must have effective verbal, written and interpersonal skills

• Able to prioritize and operate proactively

• Able to analyze situations or data



Physical Requirements:

• Lab / Non-Production Setting: 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 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 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.



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