NOI Investigative Specialist
Sterling Engineering Piscataway, NJ
- Posted: over a month ago
- Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Performs interviews and schedule follow-up meetings in response to investigations.
- Perform gap assessments and root cause analysis evaluations to determine RISK level utilizing root cause analysis tools such as FMEA, wishbone and/or 5 Why tools.
- Directly supports the business through schedule/timeline adherence of NOI closures to allow for timely ANDA submissions, new product launches, and batch releases.
- Recommend quality process improvements to increase efficiencies and performance of systems, operations and personnel and prevent reoccurrence of incident or event.
- Writes investigation reports in a clear and concise manner to withstand regulatory scrutiny, with sufficient detail to support decisions drawn and actions taken to resolve an event.
- Identify and resolve objectionable GMP issues which may impact product quality and escalate the issues to supervisor in a timely manner.
- Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as GMP and health and safety requirements in the markets where product is sold.
- As needed dons appropriate gowning and safety attire to maintain acceptable environmental conditions for maintaining product integrity and personal safety.
- Uses technical, scientific and professional judgment for assessing the effectiveness of CAPAs and communicates to supervisor and area management when deficiencies are found.
- Bachelors Degree (BA/BS): Science or Engineering, Quality Mansgement or related field - Required
- 4 years or more experience working in the Pharmaceutical or Medical Device industry is required.
- 3 years or more experience working in GMP/FDA regulated environment is required.
- 3 years or more hands on experience in a production or laboratory working environment preferred.