Quality Assurance Investigator (Pharmaceutical Solid/Aseptic Dose)

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

Responsibilities

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.

Qualifications

1. ollege Bachelor’s Degree in Natural Sciences, Pharmacy, or Engineering. Master degree is desirable, but not a must.
2. Three to five years-experience in the pharmaceutical industry preferably with supervisory experience in the manufacturing, packaging, laboratory and/or Quality Assurance areas.
3. Proficient knowledge of cGMP’s and FDA regulations.
4. Knowledge of computer systems GMP requirements for Part 11 compliance
5. Technical knowledge in pharmaceutical manufacturing processes, technologies, process validation and processing equipment.

Benefits Include:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays