Team Lead, Quality Control

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 is subordinate to departmental Senior Leadership and above, but above staff.

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

Responsible for technical leadership, operation, and oversight of QC testing relevant for manufacturing. Ensures compliance with the Quality Systems (QC), standard operating procedures (SOPs), regulatory requirements, guidance, industry standards, customer expectations, and business needs, as applicable. Stives to have team function in an efficient and accurate manner, on time, and on budget, without nonconformance.

Responsibilities

• Assists QC Manager and/or Supervisor with efficient utilization of personnel, equipment/instruments, materials, and standards for uninterrupted laboratory services supporting manufacturing operations, training activities, and other assignments. • Assists QC Manager and/or Supervisor with scheduling resources to ensure all daily tasks are completed. • Fills QC responsibility gaps, as necessary, including all essential job functions. • Collaborates with QC Manager, QC Supervisor, and Training Dept. to develop, schedule, and track training plans for direct reports. Addresses problems with work quality, issues between employees, and other concerns in an effective, timely manner. • Provides guidance to employees to ensure QC testing and processes meet the company QS, cGMPs, and safety standards. Delegates work to employees, tracks progress, and provides constructive feedback throughout projects and tasks. • Organizes workflow and ensures that employees understand their duties or delegated tasks. • Serves as point-person for troubleshooting, seeking out expertise of QC Specialists and company Scientists, and coordinating with other functional groups, as needed, to resolve technical issues and operational concerns. • Conducts/directs activities related to inventories and ensure accurate inventory levels and removal of expired items. • Provides input on method validation protocols, validation reports, and other documents/records/reports, as necessary. • Leads laboratory investigations, OOSs, root cause analysis, and corrective action/preventative action implementation, • Supports the maintenance of a cGMP-compliant laboratory environment and all equipment, software, and procedures. Develops, implements, and oversees the execution of maintenance protocols for analytical instruments/equipment. • Investigates and leads teams to solution of microbiology issues as they arise throughout the organization. • Supports Manufacturing and Technical Services activities, as needed. • Leads the establishment of appropriately robust and reliable GxP analytical methods and specifications for QC testing to support the product development life cycle. • Initiates, authors, and reviews QS records and documentation in a timely manner. Ensures data integrity. • Assists department in optimizing processes. • Assists with coordination and scheduling of testing, personnel, equipment, and laboratories. • Establishes and maintains procedures, forms, instructions, and records for sampling and testing. • Evaluates the performance of QC activities to ensure achievement of product specifications and reproducibility of activities.

• Understands the departmental budget, is aware of the impact of related expenses on the budget and raises exceptions to the manager. • Primarily responsible for the execution of day to day 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 his/her manager. • Enforces and exemplifies company policies.• Ability to present 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. • Ensures direct reports maintain focus on our customers.• 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 & 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.• Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.• 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.

Leadership Traits & Characteristics • 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 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.Full Time On-Site

Qualifications

Undergraduate degree in any Life Sciences or Engineering field or 6 years direct, relevant experience in a Quality Control laboratory testing environment to provide a comparable background Minimum of 3 years' experience in the supervision of a regulated microbiology testing laboratory including previous experience managing up to 10 direct reports

Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in OutlookBasic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

Knowledge and application of industry standards and guidelines/regulations related to the manufacturing of sterile injectable drug and biologic products (21 CFR 210 and 211) and cGMPs

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.Quality Control: • 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 at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs. • 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 but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.