Quality Assurance Assistant

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 performs record review of quality records and provides general support to QA team and QA Management.

Responsibilities

• Print and issue batch records • Review completed batch records, associated forms, and general forms for accuracy, completion, and GMP documentation. • 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 various computer applications on MS Office programs

• Exemplifies Cook MyoSite Core Values • Maintain regular and punctual attendance • Must maintain company quality and safety standards • This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above. • Ability to work in collaborative and independent work situations and environments with minimal supervision • Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability • Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals • Trainability • Must have effective verbal, written and interpersonal skills • Able to prioritize and operate proactively • Must maintain a high level of confidentiality • Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations

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

• Knowledge of cGMP regulations and good documentation practices

• Proficient knowledge of Microsoft Office software, and other general office equipment.

Physical Requirements:

Hybrid

• 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 in biological safety hood setting. • 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 safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis. • Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

• Employee that does not interact with Healthcare Professionals• Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.