Manager, Quality Assurance Specialists at Cook Myosite Inc. in Pittsburgh, Pennsylvania

Job Description:

Manager, Quality Assurance Specialists

Requisition ID 2025-15847

Posting Date 9 hours ago (1/7/2025 3:00 PM)

Job Location(s) Pittsburgh PA United States

Job Locations US-PA-Pittsburgh

Position Type Full Time

Company Cook Myosite Inc.

Category Quality

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, Quality Assurance Specialists provides technical leadership, represents the QA department on cross-functional project teams, establishes cGxP compliant processes related to QA operations, and supports training activities for the QA specialists.

Front Line Leadership is primarily tasked with departmental decisions and output on activities related to quality, operations, and the business. They are accountable to Senior Leadership and Directors for their department or functional area and are the technical experts.
Front Line Leadership functions include managing departmental resources appropriately, assessing performance, providing feedback, and identifying gaps. Front Line Leadership also must be skilled communicators, able to convey clear expectations, listen for feedback, and provide updates in a timely manner.

Responsibilities

• Collaborates with management and training personnel to develop, schedule, and track training plans for QA specialist team.
• Provides guidance on adherence to cGMPs, and safety standards
• Assists in delegation of tasks and project work, tracks progress and provides constructive feedback throughout projects and tasks
• Acts as functional point person for troubleshooting, coordination with other functional groups, and providing decision points as needed.
• Provides support and serves as backup, to the QA Specialist as well as the QA Manager in the Functional Areas
• Initiates, authors, and performs departmental review of quality system records and documentation (i.e. investigations, batch records)
• Serves as point-person for troubleshooting, seeking out expertise of QA Specialists and company Scientists, and coordinating with other functional groups, as needed, to resolve technical issues and operational concerns.
• Review and approve validation documents, pertaining to production processes, including critical control points, critical quality attributes, stability program, retention, storage, etc., within the organization to ensure the processes are planned, managed, and qualified/validated in a compliant manner.
• Facilitate authoring of investigations, especially those pertaining to Quality Assurance deviations, and assist in identification of appropriate CAPAs to address problems.
• Provide direction and support for the development and implementation of quality related processes
• Author Quality System documents
• Participates in risk assessment processes
• Perform additional activities related to overall Quality Assurance as requested by management, e.g. audits, vendor qualifications.
• Review and approval of change controls/requests, SOPs, and forms
• Promote GLP/cGMP environment and follows procedural guidelines

• Understands the departmental budget, is aware of the impact of related expenses on the budget and raises exceptions to the manager.

• 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.
• Demonstrates decisiveness by making decisions in a timely manner.
• 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.
• Builds a strong team and supports its progress with compassion and enthusiasm.
• 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.

Qualifications

• Undergraduate degree in any Life Sciences, Biomedical or related fields, or 6 years direct, relevant experience in cGMP environment to provide a comparable background

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

• Six years' experience in a biologics /medical device / biopharmaceutical manufacturing environment.
• 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

• 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.

Hybrid (3 days in office, 2 days remote)

Physical Requirements:

• 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.

Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

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.

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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.