Supplier Quality Specialist

Posting Date 2 months ago(1/20/2021 2:59 PM)
Requisition ID
2021-8424
Job Location(s)
Pittsburgh PA United States
Travel
30-40%
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 Supplier Quality Specialist is responsible for performing activities to support and assess vendor management and qualification practices.  This position ensures that vendors and providers of services, materials, equipment, and software used in the manufacture, processing, packing, or holding of products meet the external cGXP requirements and internal business requirements to which Cook MyoSite Inc. is subject.

Responsibilities

• Qualify, approve, and perform periodic reevaluation of vendors and service providers as required according to vendor management program

• Plan and conduct scheduled vendor 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 effectiveness

• Plan and conduct For-Cause audits to address critical vendor management concerns resulting from changes in vendors’ processes, previous audit findings, suspected vendor-related fraud or misconduct, etc.

• Coordinate and maintain external (vendor) audit schedule

• Maintain the Approved Supplier List and Vendor Management Files

• Author, review, or revise Supplier Quality procedures and associated records/documentation

• Participate as member of Internal Audit team, applying auditing principles and procedures to routine and for-cause assessments of cGXP compliance within QMS

• Participate as member of the Material Review Board (MRB) to provide assessment, insight, guidance, and resolution on all issues from a vendor quality impact perspective

• Active participation with the Material Management Program to develop and continuously improve processes with vendor evaluation, risk, and mitigation

• Maintain knowledge and understanding of current industry best practices to ensure Subject Matter Experts are aware of regulations/enforcement changes and compliance risks

• Review quality (or technical) agreements with vendors and ensure effective agreements are in place and being enforced by working with quality unit of vendors providing services and products that impact cGXP operations

• Exemplifies Cook MyoSite’s cultural values and aligns daily actions with department goals and company culture
• 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/biomedical quality assurance or supplier management experience or five years’ relevant pharmaceutical/biomedical quality assurance or supplier management experience 

• Minimum of 3-5 years' experience in QA, supplier quality, GMP compliance, or auditing roles in the biotech/pharmaceutical industry

• Certified Quality Auditor certification preferred, required within 12 months of accepting position

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices

• Proficient knowledge of Microsoft Office software, and other general office equipment.

• Proficiency or comfort level working with material of a highly technical or scientific nature.

• Thorough knowledge of global pharmaceutical industry regulations, standards and guidelines, such as, cGMPs (FDA, Health Canada, EMA, MHRA, PMDA), USP/EP and other Pharmacopeia, FDA Guidances, 483s, Warning Letters, EIRs etc., European Directives, Annexes, and other standards

• 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

 

Physical Requirements:

• Travel possible up to 40%, domestic and international. 

• 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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