Quality Assurance Assistant

Cook Medical; Pittsburgh (Allegheny County); Hybrid; USD 40,000 - 60,000; Full time

Job summary

Cook MyoSite, part of the Cook Group, is seeking a Quality Assurance Assistant to support QA management by performing record reviews and maintaining documentation. This hybrid role in Pittsburgh requires attention to detail and proficiency in Microsoft Office, along with a foundation in life sciences or relevant experience.

Qualifications

• 1-3 years of experience in a cGMP background.
• Knowledge of cGMP regulations and good documentation practices.
• Flexibility to work extended hours, including evenings and weekends.

Responsibilities

• Print and issue batch records.
• Review completed batch records for accuracy and GMP documentation.
• Maintain spreadsheets and databases using Excel and Access.

Skills

Attention to Detail

Communication

Documentation

Education

Associate's degree in Life Sciences or related fields

Tools

Microsoft Office

Excel

Access

Job description

Overview

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We are investigating our core technology, autologous muscle-derived cells, for the potential treatment of muscle-related disorders. Joining our team offers an opportunity to ignite your passion, grow your potential, and define your purpose. If you are curious, motivated by helping others, and driven by integrity, we invite you to apply.

Position: Quality Assurance Assistant

The Quality Assurance Assistant at Cook MyoSite performs record review of quality records and provides general support to the QA team and QA Management.

Responsibilities:

1. Print and issue batch records.
2. Review completed batch records, associated forms, and general forms for accuracy, completion, and GMP documentation.
3. Review and approve documentation related to Biopsy receipt and incoming materials.
4. Compile and review data for reports.
5. Maintain spreadsheets and databases using Excel and Access.
6. Perform clerical functions such as printing, scanning, and filing QA records and documentation.
7. Assist with process improvement projects.
8. Assist with training of other QA team members.
9. Perform various tasks using MS Office programs.

Qualifications:

1. Associate's degree in Life Sciences, Biomedical, or related fields, or 4 years of relevant experience in a cGMP environment.
2. Minimum of 1-3 years of experience in a cGMP background.
3. Knowledge of cGMP regulations and good documentation practices.
4. Proficient in Microsoft Office software and general office equipment.

Physical Requirements:

1. Hybrid position in a laboratory setting, with potential exposure to hazardous chemicals and disinfectants.
2. Ability to communicate effectively via conversation and telephone.
3. Flexibility to work extended hours, including evenings, weekends, and on short notice.
4. Ability to work under time constraints.
5. Prolonged sitting and working on a computer.
6. Ability to stand, walk, stoop, kneel, crouch, climb, reach, twist, and bend, with or without accommodations.
7. Ability to lift/push/pull up to 50 pounds occasionally.
8. Capability to perform PPE gowning procedures regularly.
9. Ability to extend arms for extended periods, up to 3 hours.

Note: This position is a hybrid role requiring presence in the laboratory and office settings.