Quality Assurance Manager

Posting Date 1 week ago(11/17/2021 3:28 PM)
Requisition ID
2021-9888
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
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 Assurance Specialist Manager at Cook Myosite, Inc. will provide technical leadership, represent the QA department on cross-functional project teams, establishe cGxP compliant processes related to QA operations, and support training activities for the QA specialists.

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

Qualifications

• Undergraduate degree in any Life Sciences or Engineering field or 6 years direct, relevant experience in a Quality Assurance role in a GMP facility

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

• 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 is preferred

 

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.

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