Kforce Senior Auditor / Enterprise Quality Audit in Chestnut Ridge, New York
Kforce is looking for a Senior Auditor for a large client in Spring Valley, New York (NY). This role offers great benefits and career growth with a growing organization.
Minimum of a BA/BS with a minimum of 5-7 years of experience in a pharmaceutical manufacturing or Quality Assurance/Compliance environment; ASQ-CQA or ASQ-CQE certified highly desired
Proficiency in a body of information required for the job (e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.)
- Possess sound technical and quality/compliance background related to pharmaceuticals/biologics with auditing experience in multiple areas, such as API, Analytical Lab, Sterile Drug Product, Contract Pkg, Mock PAI, etc.
Possesses thorough knowledge of current domestic and international standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, ISO, ICH guidelines and guidance documents)
Leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific (e.g. coaching, negotiation, calibration, technical writing, etc.)
- Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents
Demonstrates the ability to conduct GMP audits of drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials, packaging components, and analytical laboratories
Able to use Word, Excel, PowerPoint and Outlook
Excellent communication skills, both written and verbal
Physical requirements physical and mental requirements e.g. lift 40 pounds, walk across plant/warehouse, driving as part of work responsibilities, etc.
Travel - Domestic (35%)/International (15%)
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.Compensation Type:YearsMinimum Compensation:80000.00Maximum Compensation:115000.00
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