Quality Assurance Operations Supervisor

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’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 Operations Supervisor at Cook MyoSite, Inc. provides oversight and facilitates completion of daily QA activities to support manufacturing operations. Provides technical guidance to personnel completing departmental processes. 

Responsibilities

• Provide technical leadership for QA operations processes; ensuring compliance with departmental SOPs, cGMPs, and safety standards. • Collaborate with QA management to ensure effective workload distribution among the QA operations team and provide status updates on all work functions and active projects• Provide status reports on all work functions and active projects to QA management. • Review and approve documentation/records associated with incoming biopsies, materials, final products and associated data in support of cGMP operations..• Create, manage, review, and print batch records and product labels. • Participate in organizational projects and risk assessment activities as a quality representative. • Perform investigation report writing and risk assessment activities.• Conduct and document training events. • Support Investigations of customer complaints. • Participate in change management activities and quality document creation/revisions.

Qualifications

• Undergraduate degree in any Life Sciences or related field, or 4years direct experience in regulated industry to provide a comparable background

• Minimum of 3 years of Quality Assurance experience in a GMP facility

• Proficiency in MS Office applications; Outlook, Teams, Excel, Word, PowerPoint, OneNote, as well as Adobe Acrobat• 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:

• Full Time Onsite position

• 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.• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.