18 days old

Quality Assurance Compliance Specialist

Cook Myosite Inc.
Pittsburgh, PA 15219
  • Job Code
    2020-7357


  • Quality Assurance Compliance Specialist

    Posting Date 4 hours ago (1/30/2020 2:26 PM)

    Requisition ID 2020-7357 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

  • Bachelor's degree or higher, in any life science, biomedical, or related fields

  • Minimum of three years' experience in a pharmaceutical or biomedical quality assurance role or five years' experience in other pharmaceutical or biomedical industry roles
  • Experience conducting internal or external auditing is preferred
  • Experience interacting with health authority personnel in an inspection capacity is preferred
  • Trainability and an ongoing commitment to learning, improvement of personal and organizational knowledge, and development of job skills and abilities
  • Must possess excellent organizational skills, planning, scheduling, the ability to follow and help drive complex processes, procedures and systems
  • Must have effective verbal, written and interpersonal skills

  • Understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
  • Demonstrate leadership, critical thinking and ability to assist in carrying out departmental goals set by Management
  • Maintain composure and competence under stressful situations; flexibility and adaptability
  • Ability to work in collaborative and independent work situations and environments with minimal supervision
  • Willingness and capability to handle multiple projects and responsibilities
  • Achieve ASQ Certified Quality Auditor certification within 2 years of employment within the Quality Compliance Dept
  • High proficiency in MS Office and other general office software and equipment

    Physical Requirements:

  • General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II area
  • Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time

  • Ability to conduct and hear ordinary conversation and telephone communication
  • Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
  • Visual and manual acuity for working with computers and equipment

  • Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
  • Must be able to perform PPE gowning procedures on a frequent basis to enter BioSafety Level II area including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis

  • 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
  • Travel possible up to 10%

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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.







  • Posted: 2020-01-31 Expires: 2020-02-29
    Sponsored by:
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    Sponsored by:
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    Cook Myosite Inc.
    Pittsburgh, PA 15219

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