POSITION OVERVIEW

Conduct and write formal investigation of process deviations for Manufacturing with the assistance of site personnel. This position will also perform initial and final impact risk assessment as well as assist in root cause determination and plan appropriate corrective action and preventative action. The incumbent will also assist in the tracking and trending of historical data and assure timely closure.

DUTIES AND RESPONSIBILITIES

• Ensure compliance with relevant SOP's while gathering, analyzing and applying information from

internal and external sources in order to perform a risk assessment of the impact each process

deviation and complaint has on the product, process and patient health and safety.

• As part of the investigation, gather information from all necessary internal and external sources

in order to evaluate the impact of the deviation on previously manufacturing product, as well

as the risk to future operations.

• Leads and support investigations across Manufacturing, Packing and other departments to ensure

timely closure for each investigation and follow-up activities.

• Works with the functional areas to identify the most probably root cause(s) and determine

appropriate preventative and corrective actions.

• Trend and analyze product compliant investigation data and address appropriate as well as

liaison with production and quality.

• Work independently to comply with procedure driven guidelines relating to deviation and complaint investigations.
• Conduct interviews with site personnel to gather data for the deviation report.
• Perform as the lead in root cause problem-solving sessions.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree (Biology, Microbiology, Chemistry, Pharmacy or similar)
• 3-5 years related experience in a cGMP facility
• 3-5 years of deviation, investigative writer experience or equivalent technical writing experience
• Advanced writing skills
• Strong critical thinking and deductive reasoning skills
• Excellent interpersonal and communication (written and verbal) skills
• Strong MS Office skills
• Understanding of QA practices and standards is preferred