Requisition ID 2021-8404 Job Location(s) Pittsburgh PA United States Travel 10-20% 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 Compliance Specialist is responsible for monitoring, auditing, and management of quality compliance systems and providing leadership in continuous improvement efforts for the GMP manufacturing process and other GXP control systems at Cook MyoSite, Inc.
Responsibilities
Lead internal GMP, GDP and GLP auditing processes; prepare and review audit reports
Perform gap assessments against global cGMP and cGXP standards to support quality and compliance initiatives
Coordinate and maintain an internal audit schedule to assess performance of all operations
Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to vendors, internal policies etc.
Plan and conduct scheduled audits to assess compliance with FDA, ISO, ICH, internal requirements, etc., including audit scheduling, investigation, and evaluation of audit observation and findings, reporting, and verification of audit response effectiveness
Support company-wide FDA Pre-Approval Inspection- readiness initiatives
Performs review and oversight of vendor qualification activities
Assists and works in conjunction with, auditees and other auditors during an audit in the capacity of a liaison
Conducts and documents compliance-related training events
Exemplifies Cook MyoSite's cultural values and aligns daily actions with department goals and company culture
Demonstrates professional behavior with both internal and external customers that reflects positively on the company and is consistent with the company's policies and practices
Maintain regular and punctual attendance
Must maintain company quality and safety standards
Promotes awareness of quality, compliance, and regulatory requirements
Qualifications
Undergraduate degree in any Life Science, Biomedical, or related field plus 2 years of direct, relevant pharmaceutical or biomedical quality assurance role experience or five years' experience in other pharmaceutical or biomedical industry roles
Minimum of 1-3 years' experience in conducting internal or external auditing
Experience interacting with health authority personnel in an inspection capacity preferred
Achieve ASQ Certified Quality Auditor certification within 1 year of employment within the Quality Compliance Department
Proficient knowledge of Microsoft Office software, and other general office equipment
In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices
Proficiency or comfort level working with material of a highly technical or scientific nature
Project management experience or experience as part of a project team or project team leader preferred
Ability to work in collaborative and independent work situations and environments with minimal supervision
Must have effective analytical and data interpretation skills as well as effective verbal, written and interpersonal skills
Able to prioritize and operate proactively
Physical Requirements:
Travel possible up to 10%
Lab / Non-Production Setting: 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 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.
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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.
