Manager, Investigations, CAPA and Complaints

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 Manager, Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing all activities performed by the Investigations Writing team. The manager works closely with QA Management to ensure Investigations, CAPAs, and Complaints are completed in a compliant and timely manner. In addition, this position is required to assess the capabilities of the Investigations Writing team, develop the team for subject matter expertise, and create a business continuity plan for the department. 

Responsibilities

• Assists QA Management and QA Specialist with efficient utilization of personnel for deviation writing and approval processes supporting manufacturing operations• Escalates investigations roadblocks to appropriate management as needed• Continuously evaluate priorities of investigations and manage accordingly • Functions as the Designated Trainer for the process to include but not limited to Investigations, CAPA Management, Event Reporting, Complaints, and Trending to ensure adequate and proficient training is provided. • Function as the SME on Investigations, CAPAs & Complaints for internal/external audits, contributes to the development of responses to observations. • Manage outsourced contingent resources for investigations-related work • Review and approve investigations, complaints, and CAPA’s • Develop corrective and preventative action plans (CAPAs) and guide assigned department management or designee for implementation • Keeps up to date on current events in pharmaceutical and biotechnology industry • Lead self-developed departmental initiatives • Remains qualified to participate in and/or lead investigations activities and actively does so as needed/required• Develops business continuity processes for the investigations, CAPA, and Complaints• Provides data on the management of Investigations & CAPAs, trends, critical issues for Management Review, Strategy meetings, company/department scorecards, internal/external audits, etc. as part of the continual improvement process.

Qualifications

• Undergraduate degree in chemical engineering, biology, biotechnology, or 7 years direct, relevant experience in investigations writing, CAPA management, complaints and change control process to provide a comparable background

• Minimum of 5 years' experience in applying GMP requirements. • Minimum of 5 years’ experience in biology/biochemistry environment to understand the methodology associated with manufacturing a cell therapy product in an FDA-regulated environment. • Experience in Quality Assurance and/or Compliance functions and Investigations/CAPAs including at least 4 years authoring and reviewing SOPs. • Experience Training others.

• Knowledge of change control process • Knowledge of electronic documents management system• Knowledge of metrics creation and data analysis• Knowledge of quality risk management guideline (Q9)• Experience in employee development • Experience with regulatory agency/health authority audits/inspections • Data analysis • Lean and Six Sigma fundamental understanding

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook• 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:

• Hybrid 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. 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.