Quality Assurance Assistant

Posting Date 2 months ago(4/16/2021 3:18 PM)
Requisition ID
2021-8850
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 Assistant at Cook Myosite Inc. performs record review of quality records and provides general support to the QA team and QA Management.

Responsibilities

• Review completed batch records, associated forms, and general forms for accuracy, completion, and GMP documentation.
• Print and issue batch records

• Review and approve documentation associated with Biopsy receipt

• Review and approve documentation associated with incoming materials

• Compile and/or review data compiled for reports.

• Maintain spreadsheets and databases using Excel and Access

• Clerical functions such as printing, scanning, and filing of QA records and documentation

• Assist with process improvement projects

• Assist with training of other QA team members  

• Perform work using various computer applications

Qualifications

• Associates degree in Life Sciences, Biomedical or related fields or 4 years of direct, relevant experience in cGMP environment to provide a comparable background
• Minimum of 1-3 years' experience in cGMP background preferred, including knowledge of regulations and good documentation practices (GDP)
• 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.
• Must have effective verbal, written and interpersonal skills
• Ability to work in collaborative and independent work situations and environments with minimal supervision 
 

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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