Quality Control Supervisor

Posting Date 2 months ago(12/2/2020 4:11 PM)
Requisition ID
2020-8231
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) Supervisor at Cook MyoSite will oversee QC laboratory testing activities and provide technical guidance to personnel for microbiology assays, molecular biology assays, and environmental monitoring (EM) of production environments.

Responsibilities

• Provide technical leadership for all microbiology, molecular biology, and environmental testing activities; ensure compliance of testing activities with departmental SOPs and GMP requirements

• Perform quality control sampling and testing of materials and products for identity, strength, quality, and purity utilizing assays for, but not limited to, DNA isolation, mycoplasma, endotoxin, myogenic differentiation, and desmin

• Perform GMP lot release and in-process testing for microbiology-based methods, such as growth promotion, gram staining, and sterility, in support of manufacturing process

• Perform EM data review, trending, and analysis

• Review peer laboratory data, ensuring the highest standards of data integrity are upheld and product specifications are achieved

• Analyze equipment and test method data using statistical tools to ensure systems remain in a state of control

• Lead the investigation of nonconformance activities by performing investigation protocols, conducting additional testing as needed, and authoring investigation reports

• Assist in overseeing the testing of in-process materials and products in conjunction with production schedules

• Work with the QC Manager and department training coordinator to ensure all personnel are demonstrating required proficiency for all testing procedures

• Utilize the Laboratory Information Management System (LIMS) to enter/track incoming samples, enter analytical data, and perform technical review of test data

• Recommend and establish different methods for performing QC tasks

• Author quality system records, such as SOPs, deviations, and CAPAs

• Perform QC projects for validation and evaluation of methods

• Handle and work with microorganisms

• Assist team in preparing and testing reagents, general laboratory maintenance/cleaning, material inspections, and monthly inventories, when needed

• Maintain regular and punctual attendance

• Must maintain company quality and safety standards

Qualifications

• Undergraduate degree in Life Sciences, preferably Molecular Biology or Microbiology, or related field or 6 years direct, relevant professional experience performing microbiology and molecular biology assays to provide a comparable background

• Minimum of 3-6 years' experience in monitoring production environments in a GMP facility 

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook 

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)  

 

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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