Employment Agency

dive_staffing

Investigations Writer

Fulltime, Contract

Job Description

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 finalizing 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. Responsible for writing and reviewing Risk Assessment Report per Q9. Responsible for writing and reviewing Protocols and Reports.

Responsibilities :

Requirement :

Career Level

Associate / Quality Assurance

Job Specializations

Quality Assurance / Investigations Writer

Qualification

College bachelor’s degree in Natural Sciences, Pharmacy, or Engineering. Master’s degree is desirable, but not a must.

Year of Experience

3 to 5 years of experience.

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