Quality Assurance Process Specialist

Posting Date 1 month ago(4/29/2021 5:14 PM)
Requisition ID
2021-8922
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

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 Process Specialist provides QA oversight of the development, planning, implementation, and maintenance of the production processes to ensure procedural and external regulatory requirement compliance.
 

Responsibilities

• Understand, interpret, and apply regulatory requirements pertaining to production of a cell therapy product, in a FDA-regulated environment.

• Function as a quality subject matter expert in production processes and methods as a quality representative on project teams.

• Review and approval process of validation documents, pertaining to production processes, including critical control points, critical quality attributes, stability program, retention, storage, etc., within the organization to ensure the production process is planned, managed, and qualified/validated in a compliant manner.

• Facilitate authoring of investigations, especially those pertaining to production deviations, and assist in identification of appropriate CAPAs to address problems.

• Perform review and approval processes for Production investigations for both CAPA implementations and closure activities.

• Review and approval of production related change controls/requests, SOPs, and forms to ensure that test methods are performed in a compliant manner and meet their intended purpose.

• Author Quality System documents.

• Participate in risk assessment processes.

• Review and approve prepared material, cell therapy intermediate and final product batch records and associated records and disposition accordingly.

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

• Promote GLP/cGMP environment and follow procedural guidelines.

Qualifications

• Undergraduate degree in any Life Science or related Engineering field and 1-3 years’ experience in pharmaceutical/biopharmaceutical industry or 6 years of direct, relevant experience in pharmaceutical/biopharmaceutical quality assurance to provide a comparable background.
• Minimum of 1-3 years' experience in applying GMP requirements and sufficient biology/biochemistry to understand the methodology associated with manufacturing a cell therapy product in an FDA-regulated environment.

• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems.
• Proficient knowledge of Microsoft Office software, and other general office equipment.

• Ability to learn new systems and processes, and the ability to provide technical training.

• 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:

• 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 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 at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.

• 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 but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.

 

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