Quality Control Associate

Posting Date 1 week ago(10/16/2020 12:32 PM)
Requisition ID
2020-8025
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 Associate at Cook MyoSite will aid in the development and maintenance of methods for sampling, testing, evaluating, and approving testing results for products and materials.

Responsibilities

• Performs 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 differention, and desmin

• Performs lot testing

• Assists in the investigation of nonconformance activities with additional testing and evaluation activities as needed

• Writes quality plans and reports to QC-related activities

• Performs QC projects for validation and evaluation of methods

• Recommends and establishes different methods for performing QC tasks

• General maintenance of side labs

• Aids in activities related to monthly inventories and removal of expired products

• Cell culturing for lot testing and research

• Supports in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices

Qualifications

• Undergraduate degree in Life Sciences, preferably Molecular Biology or Microbiology, or related field or 6 years direct, relevant professional experience with analytical testing laboratory duties to provide a comparable background

• Minimum of 1-3 years' experience in biopharmaceutical testing environment preferred

• Working knowledge of Microsoft Office software

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

 

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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