Quality Control Specialist II

Posting Date 3 months ago(3/10/2022 11:07 AM)
Requisition ID
2022-10474
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 Control Specialist II at Cook MyoSite Inc. is a subject matter expert (SME) in Quality Control testing activities and processes who provides technical leadership to department personnel and represents the QC department on cross-functional project teams.

 

Responsibilities

• Provide technical guidance for all QC testing activities and ensure compliance with departmental SOPs and GMP requirements.
• Support the maintenance of a cGMP compliant laboratory environment and all included instruments and procedures.
• Lend direction and support to phase-appropriate method development, validation, and transfer to QC laboratories for drug substance and drug product release and stability testing.
• Lead laboratory investigations, root cause analysis, and corrective action/preventative action implementation.
• Author, review and approve Quality System documents and records including SOPs, investigations, CAPAs and change controls. Review and approve validation documents such as method validation and instrument/equipment protocols and reports.
• Develop, implement, and oversee the execution of maintenance protocols for testing instruments.
• Serve as a point-person for troubleshooting. Coordinate with other functional groups, as needed, to resolve technical issues and operational concerns.  
• Support manufacturing and technical services activities as needed.
• Support the product development life cycle by aiding the establishment of analytical methods and specifications.
• Maintain procedures for sampling and testing practices to assess the Safety, Identity, Strength, Purity, and Quality of material/products.
• Review QC data and develop strategy for changes, as needed.
• Author quality plans and reports for QC related activities.
• Compile and present QC metrics to communicate laboratory outputs and maintain a state of control.
• Present results of work, interpret data, and draw conclusions regarding presented material and nature of work.
• Act as a subject matter expert in presenting QC activities and practices.

Qualifications

• Master’s degree in any Life Sciences or Engineering field or undergraduate degree plus 2 years direct, relevant experience in a Quality Control laboratory testing environment

• Minimum of 4+ years’ experience in a cGMP Quality Control laboratory

• 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 is preferred

• Proficiency or comfort level working with material of a highly technical or scientific nature.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Up to date with changes in technology and the business implications/applications of new technologies

 

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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