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Primary responsibility is to investigate, document and bring to conclusion the outcome of product/processing related incidents, deviations or documentation errors reported to the site QA. The investigations assigned include manufacturing and packaging, finished product, raw materials, components, product storage/distribution and customer complaints. Coordinates the required activities with the functional areas to obtain and compile the appropriate information that can lead to finalize the investigation report. Utilizes investigative tools and techniques to identify and evaluate the cause of an event including root cause analysis, impact or risk analysis, corrective and preventative actions and monitoring effectiveness of implemented actions to comply with the FDA cGMPs investigation requirements/guidelines. Recommends, proposes and formalizes alternatives for the improvement of processes, utilities and systems.

Requirements

1. Responsible for thoroughly investigating events as it relates to deviations and customer complaints communicated to or informed by QA and applying a science-based approach to accurately, correctly and timely document the final report utilizing appropriate investigation techniques and/or tools.
2. Reviews and uses the established follow up mechanism to ensure that applicable investigations are initiated, timely completed, final reports issued and approved by QA.
3. Evaluates and discusses the impact of the reported events to ensure that its effect on previously approved product has been considered as part of the investigation process and that actions are identified to prevent its recurrence.
4. Reviews and evaluates each event under investigation against the applicable metrics defined/implemented to monitor the effectiveness of corrective and/or preventive actions and communicates results to site management on the established frequency or as agreed upon.

Benefits

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays