NOI Investigations Specialist

About the role

The NOI Investigations Specialist plays a critical role in ensuring product quality, compliance, and patient safety by conducting comprehensive investigations into quality events that may impact the manufacturing, release, distribution, or shelf life of commercial products.

Responsibilities

• 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.
• 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.

Qualifications

• Bachelor's Degree (BA/BS) in Science or Engineering, Quality Management or related field - Required
• 3 years or more in Working in the Pharmaceutical or Medical Device industry
• 3 years of Experience working in GMP/FDA regulated environment
• 3 years on Hands on experience in a production
• Use of Risk Assessment tools