Government, Regulatory and Code, Pharmaceutical, Quality, Quality Engineering
4 Year Degree
The Quality Compliance System Specialist is responsible for management of all GMP-compliance systems and provide leadership in continuous process efforts for the GMP manufacturing process at Cook MyoSite, Inc.
• Perform gap assessments against global cGMPs to create and maintain a list of compliance initiatives • Coordinate and maintain an internal audit schedule to assess performance of all operations • Lead internal GMP, GDP and GLP auditing processes; prepare and review audit reports • 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. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, and verification of effectiveness
• Perform vendor qualification activities • Perform deviation processes • Assist and work in conjunction with, auditees and other auditors during an audit in the capacity of a liaison • Conduct and document training events • Exemplify Cook MyoSite’s cultural values and aligns daily actions with department goals and company culture • Demonstrate professional behavior with both internal and external customers that reflects positively on the company and is consistent with the company’s policies and practices
• Bachelor's degree or higher, in any Life Science, Biomedical, or related fields, or acceptable related experience, minimum of two years
• Must possess excellent organizational skills, planning, scheduling, the ability to follow and help drive complex processes, procedures and systems
• Demonstrate leadership, critical thinking and ability to assist in carrying out departmental goals set by management
• Willingness and capability to handle multiple projects and responsibilities
• High proficiency in MS Office and other general office equipment • Must maintain a high level of professionalism, business acumen • Must have effective verbal, written and interpersonal skills • Maintain composure and competence under stressful situations; flexibility and adaptability • Ability to work in collaborative and independent work situations and environments with minimal supervision • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing • Must maintain valid passport • Achieve ASQ certification within 2 years of employment within the Quality Compliance Department
• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
• 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 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 25%
"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, and local law.
About Cook MyoSite
Cook MyoSite, Incorporated was formed in 2002 to guide the Cook Group organization into the expanding world of cellular technologies. Today, Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. Our goals are simple: making regenerative medicine a part of everyday medicine and becoming the most trusted name in cellular therapy.