Team Lead, Investigations

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.

Team Lead Leadership is tasked with the execution of day-to-day departmental decisions and output. Team Lead Leadership manages daily tasks and provides guidance to team members for the completion of assigned tasks.

Team Lead Leadership functions revolve around being the technical expert for the department and oversees direct reports and personnel development. Team Lead Leadership also demonstrates the ability to develop and execute short-term and long-term development plans.

The Team Lead, Investigations is responsible for leading the daily activities of the Investigations team, such as assigning and reviewing deviation investigations, and mentoring and developing investigations writers to meet performance objectives for the department. The Team Lead works closely with QA Management to ensure investigations are completed in a compliant and timely manner.

Responsibilities

• Assists QA Management and QA Specialist with efficient utilization of personnel for deviation writing and approval processes supporting manufacturing operations. • Assists QA Management and QA Specialist with scheduling resources to ensure all daily tasks are completed. • Collaborates with the Training department, QA Management, and/or Impacted Department Management to support personnel training plans in alignment with functional roles• Addresses issues with work quality, employee conduct, and other concerns in an effective, timely manner. • Reviews and approves deviation investigations work • Participates in investigations discussion meetings as subject matter expert • Conducts deviation investigations in compliance with Cook Myosite quality requirements and timelines• Conducts interviews, walkthroughs, physical examinations of evidence, and/or literature searches as needed to complete deviation investigations • Communicates status of deviation investigations to impacted department management as needed• Escalates deviation investigation roadblocks to appropriate management as needed• In conjunction with QA, develops and reports on metrics related to deviation investigations • Evaluates requirements of corrective and preventive actions (CAPA) during the investigation process, and works with the QA specialist and impacted departments to develop appropriate CAPA implementation plans and effectiveness checks • Develops standard operating procedures and other quality documentation • Mentors Investigation writers through coaching and constructive feedback• Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.• Conducts and documents training events• Develops business continuity processes for the Investigations team

• Understands the departmental budget, is aware of the impact of related expenses on the budget, and raises exceptions to management • Primarily responsible for the execution of daily departmental decisions and output• Effectively delegates and follows up on completion of work.

• Understands the departmental budget, is aware of the impact of related expenses on the budget, and raises exceptions to management • Primarily responsible for the execution of daily departmental decisions and output• Effectively delegates and follows up on completion of work.• Regularly and consistently provides status reports on all work functions and active projects to management. • Enforces and exemplifies company policies.• Presents complex information in a clear and comprehensive manner.• Is an effective communicator with internal and external stakeholders. Conveys clear expectations, actively listens to input, and responds to feedback appropriately and in a timely manner.• Is action orientated and follows up on feedback to ensure positive outcomes.• Accountable for all stated responsibilities including progress, accuracy, and timely completion of objectives.• Is a critical thinker with proven problem-solving and decision-making abilities. • Exhibits well-developed prioritization, planning, organization, and time management skills.• Possesses the ability to develop and implement complex processes, procedures, and projects within their systems• Demonstrates ability to develop and execute short-term and long-term development plans.• Oversees direct reports and supports personnel development • Develops and leads department staff through direct observation and active feedback on an ongoing basis.• Ensures that departmental status meetings are held on regular basis and conducts monthly one-on-one meetings with direct reports• Directly responsible for department/function staff resource planning.• Manages departmental resources appropriately and implements processes.• Participates in the recruitment of staff.• Is the departmental/functional area technical expert.• Makes day -to-day decisions on activities related to quality, operations, and the business.

Qualifications

• Undergraduate degree in chemical engineering, biology, biotechnology, or related discipline, or 6 years direct, relevant experience in investigations writing, CAPA management, and change control process to provide a comparable background • Minimum 1-3 years’ experience with Investigations writing

• 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)

• Minimum of 1-3 years' supervisory experience in a GMP facility Investigations writing • Experience with CAPA process• Knowledge of change control process• Knowledge of electronic documents management system• Knowledge of metrics creation and data analysis• Knowledge of root cause analysis tools• Knowledge of quality risk management guideline (Q9)

• Communicates and exemplifies Cook MyoSite core values.• Demonstrates strong interpersonal skills resulting in exceptional rapport with people. Proven success initiating, promoting and maintaining strong interpersonal relations• Is a teacher and trusted leader.• Identifies and effectively manages conflict.• Proactively and appropriately challenges the status quo and champions change for the advancement of the organization.• Is a positive influence within the company and supports it, and their colleagues, both publicly and privately.• Demonstrates passion for our mission even through times of challenge and adversity.• Understands and embraces the company vision and inspires others to realize it.• Is decisive and able to employ the appropriate balance of risk taking and judiciousness.• Promotes a healthy culture aligned with MyoSite's values.

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.• Non-Production:• 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 a 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.• Must be capable of performing PPE gowning procedures 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.

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.