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FDA Pharmacovigilance Auditor

SQA Services  –  New York City, NY
... What you’ll need: You will need to have expertise in US FDA Pharmacovigilance regulations. You will need experience managing PV agreements with multiple parties and assertiveness dealing with difficult auditees. As an SQA Quality Auditor, you will ... - Apr 22

Quality Assurance Manager for Pharmaceutical Packaging

Carecam International Inc  –  Fairfield, NJ
... The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall ... - Apr 03

Quality Assurance Manager

Schreiner Group  –  Blauvelt, NY, 10913
... · Knowledge of cGMP/QSR, ISO:9001, ISO:14001, ISO:45001, IATF 16949 and FDA device/drug/biologics regulations. · Experience with Lean Manufacturing principles, 5S and other productivity and quality improvement methods. · Intermediate to advanced ... - Apr 19

Operations Associate

Cardiovascular Research Foundation  –  Orangeburg, NY, 10962
... Provides regulatory support to business unit by assisting with audit preparation, interacting with auditors, and conducting follow-up activities and communications with external parties including but not limited to the FDA, USDA, NY State, etc. ... - Apr 28

Quality Specialist/Quality Engineer

Extremity Medical  –  Parsippany, NJ
... Develop and implement quality management system, strategy and plans to ensure compliance with FDA QSR, ISO 13485, MDD 93/42/EEC and other regulatory requirements in accordance with company goals. 2. Support the Management Representative by ... - May 01

Director, Regulatory Affairs Strategy

NS Pharma, Inc.  –  Paramus, NJ, 07653
... Other duties may be assigned.) Serves as a liaison to FDA and provides strategic input to CROs and their regional regulatory leads responsible for ex-US regulatory activities. Provide oversight of regulatory consultants and vendors where applicable. ... - Apr 19

Quality Assurance Manager

Schreiner Group LP  –  Blauvelt, NY
... · Knowledge of cGMP/QSR, ISO:9001, ISO:14001, ISO:45001, IATF 16949 and FDA device/drug/biologics regulations. · Experience with Lean Manufacturing principles, 5S and other productivity and quality improvement methods. · Intermediate to advanced ... - Apr 16

Buyer

G.A. Rogers & Associates  –  Fairfield, NJ, 07004
... Essential Duties: All ingredients and materials must be in compliance with FDA 21 CFR 111 – GMP’s for Manufacturing, Packaging and Holding of Dietary Supplements. Use QA/QC approved, qualified vendors only. All materials and packaging components ... - Apr 28

Senior Manager Quality Assurance Validation Computerization Systems

Lynkx Staffing LLC  –  Saddle River, NJ, 07458
Job Description The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA ... - May 02

Registered Nurse

Kelly Science, Engineering, Technology & Telecom  –  Montvale, NJ, 07645
... RN from OR, Anesthesia, ICU, Critical Care, preferred Experience in a Sales/Marketing commercially aligned group preferred Knowledge of FDA regulations and pharmaceutical processes a plus - May 02
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