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Supplier Quality Specialist

Cook MyoSite

This is a Full-time position in Pittsburgh, PA posted March 27, 2021.

nn Overview nn nnCook 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.nn nn nn nnThe 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.nn nn n nn nn Responsibilities: nn 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 Promote awareness of quality, compliance, and regulatory requirements nn n nn nn Qualifications: nn Undergraduate degree in any Life Sciences, or 2-4 years of direct, relevant experience in Regulatory Affairs publishing to provide a comparable background Minimum of 2-4 years of experience in Regulatory Affairs or GMP/GCP setting Advanced proficiency in MS Office, specifically, advanced knowledge of Adobe, OneNote, Excel, Word and PowerPoint Experience creating technically compliant regulatory submissions using technology such as MS Word and Adobe Pro preferred Demonstrable knowledge of eDMS and regulatory information submission applications Knowledge of regulations and guidelines governing biological product development (particularly clinical) preferred Must work and interact effectively and professionally with others Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision nn nn nn Physical Requirements: nn Travel and Laboratory Settings: 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.

nn n nn nn 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.

nn nn n nn nn This posting 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.