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Posted: Friday, January 13, 2017 7:22 AM


COOK MYOSITE INCORPORATED, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time GMP Compliance Auditor to ensure assessment activities are performed to support and assess cGMP operations. The candidate will also ensure all vendors, services, contractors, materials, equipment, and software, that are used in the manufacture, processing, packing, or holding of products meet cGMP requirements.

Essential Job Functions/Duties
• 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.
• Coordinate and conduct cGMP audits of external vendors and contractors to assess acceptability of services and products provided.
• Coordinate and maintain an internal and external (vendor) audit schedule to assess performance of all operations.
• Review and ensure quality (or technical) agreements are established with vendors and contractors that provide services and products that impact cGMP operations.
• Apply auditor principles, procedures, and methods, prioritize and focus on matters of significance, collection information through effective interviewing, listening, reviewing documents, records, and data
• Strong knowledge and understanding of industry standards and guidelines, such as, global pharmaceutical cGMPs, cGMPs (FDA, Health Canada, EMA, MHRA, PMDA), USP/EP and other Pharmacopeia, FDA Guidances, 483s, Warning Letters, EIRs etc., European Directives, Annexes, and standards.

Required Experience
• A Bachelor’s degree in the Pharmaceutical or Life Sciences degree or equivalent.
• 3 – 5 years experience with GMP compliance, preferably in the pharmaceutical industry.
• Experienced with MS Office Suite, MS Project, MS Power Point, and MS Visio.
• Certified Quality Auditor certification preferred.
• Must have excellent written and oral communication skills.
• Ability to work extended hours beyond normal work schedule to include evenings and weekends with short notice.
• Ability to travel 25-50% of the time.

Cook Myosite offers a handsome benefits package which includes Competitive Salary, Health/Dental/Vision Coverage, Company Paid Life Insurance, Company Paid Short Term Disability, Paid Time Off upon hire, Paid Holidays upon hire, 401(k) Eligibility upon hire, Profit Sharing, Company Incentive Bonuses, and an Educational Assistance Program.

Please note that resumes sent without a cover letter and salary requirements will not be considered.

Candidates may apply

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”

• Location: Pittsburgh, Pittsburgh, PA 15238

• Post ID: 36481819 pennsylvania is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017