Quality Control Specialist

Posting Date 2 months ago(12/2/2020 4:29 PM)
Requisition ID
2020-8232
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 (QC) Specialist 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

• Provides technical leadership for all microbiology, molecular biology, and environmental testing activities; ensure compliance of testing activities with departmental SOPs and GMP requirements 
• Sets strategy for environmental/microbial control, microbiology method development, data review, and engagement with regulatory authorities as needed 
• Lends direction and support to phase-appropriate analytical method development, validation, and transfer to QC laboratories for drug substance and drug product release and stability testing 
• Reviews and approves method validation protocols and validation reports, as necessary 
• Leads laboratory investigations, OOSs, root cause analysis, and corrective action/preventative action implementation 
• Regularly reviews QC data and sets strategy for changes, as needed 
• Supports the maintenance of a cGMP compliant laboratory environment and all included equipment, software, and procedures Develops, implements, and oversees the execution of maintenance protocols for analytical instruments 
• Investigates and leads teams to solution of analytical technical issues as they arise throughout the organization 
• Supports manufacturing and technical services activities as needed 
• Works with Plant Operations for any quality testing of water/clean steam systems as needed 
• Leads the establishment of appropriately robust and reliable GxP analytical methods and specifications for QC testing to support the product development life cycle 
• Leads biologics testing support for process and cell line development 
• Works to advance the development of state-of-the-art techniques to characterize biologics 
• Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work 
• Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes 
• Make contributions to scientific literature and conferences or regulatory filings 
• Establishes and maintains procedures for the sampling and testing of attributes that affect the Safety, Identity, Strength, Purity and Quality of materials/products 
• Evaluates the performance of quality control activities to ensure achievement of product specifications and reproducibility of activities 
• Ensures that all final product release specifications have been met 
• Develops processes/procedures to ensure that all finished products conform to established standards of quality, appearance and consistency 
• Develops and analyzes statistical data and product specifications to ensure products meet established quality standards 
• Compiles and presents Quality Control metrics to communicate laboratory outputs and assurance of control 
• Directs/coordinates control stability testing as required 
• Acts as subject matter expert in presenting Quality Control activities and practices 
• Writes quality plans and reports to QC-related activities 
• Recommends and establishes different methods for performing QC tasks 

Qualifications

• Master's degree in any Life Sciences field or undergraduate degree in any Life Sciences field plus 2 years of direct, relevant microbiology and/or molecular biology laboratory experience 

• Minimum of 6+ years technical experience in a microbiology and/or molecular biology laboratory setting 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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