Quality Control Microbiology Team Lead

Posting Date 1 week ago(7/20/2021 3:00 PM)
Requisition ID
2021-9317
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

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 Control Microbiology Team Lead at Cook MyoSite is responsible for technical leadership, operation, and oversight of QC microbiology testing relevant for manufacturing. Team Lead is subordinate to the Manager of Quality Control (QC) Laboratory and above direct performed by QC Laboratory personnel in collaboration with the QC Supervisor and the QC Manager, ensures compliance with the Quality System (QS), standard operating procedures (SOPs), regulatory requirements and guidance, industry standards, customer expectations, and business needs, as applicable and strives 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

Qualifications

• Bachelor's 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, OneNote, Excel, Word and PowerPoint

• Knowledgeable in the use of Adobe. Expert in Outlook
• Basic understanding of cGMPs and related regulations associated with Bio/Pharmaceutical product manufacturing (i.e., 21 CFR Parts 11, 210/211)

• 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

• 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

 

 

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