Quality Compliance Gxp Auditing Specialist

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 Compliance GXP Auditing Specialist at Cook MyoSite, Inc. 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. 

• Lead internal GMP, GCP, GDP and GLP auditing processes; prepare and review audit reports
• Lead and 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 and general audit and inspection-readiness efforts
• Performs review and oversight of vendor qualification activities, including vendors supporting GMP and GCP 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
• 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
• Promotes awareness of quality, compliance, and regulatory requirements

• Undergraduate degree in any Life science, Biomedical, or related field plus 5 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

• Achieve ASQ Certified Quality Auditor certification within 2 years of employment within the Quality Compliance Dept

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

• Proficiency or comfort level working with material of a highly technical or scientific nature.
• Proficient knowledge of Microsoft Office software, and other general office equipment.

• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Must possess the ability to understand and follow complex procedures and systems
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.

Physical Requirements:

• Full Time Remote position

• Laboratory Setting (Non-Production): 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.
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.