Investigations Writer Lead
3 weeks ago
KVK Tech is seeking a skilled Investigations Writer Lead to join our Quality Assurance team. This role requires strong technical writing skills, attention to detail, and the ability to work under pressure.
The salary for this position is estimated to be around $70,000 - $100,000 per year, depending on experience and qualifications.
About the Role:
This is a unique opportunity to work in a fast-paced environment where you will investigate product/processing related incidents, deviations, or documentation errors reported to the site QA. You will be responsible for thoroughly investigating events as it relates to deviations and customer complaints, applying a science-based approach to accurately document the final report utilizing appropriate investigation techniques and/or tools.
You will review and use established follow-up mechanisms to ensure that applicable investigations are initiated, timely completed, final reports issued, and approved by QA. Additionally, you will evaluate and discuss the impact of 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.
Key Responsibilities:
* Thoroughly investigate product/processing related incidents, deviations, or documentation errors reported to the site QA.
* Review and use established follow-up mechanisms to ensure that applicable investigations are initiated, timely completed, final reports issued, and approved by QA.
* Evaluate and discuss the impact of 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.
* Communicate results to site management on the established frequency or as agreed upon.
Requirements:
* A Bachelor's Degree in Natural Sciences, Pharmacy, or Engineering is required, with a Master degree being desirable but not necessary.
* Three to five years-experience in the pharmaceutical industry, preferably with supervisory experience in manufacturing, packaging, laboratory, and/or Quality Assurance areas.
* Strong technical writing skills, attention to detail, and the ability to work under pressure.
* Knowledge of cGMP regulations and FDA guidelines, as well as computer systems GMP requirements for Part 11 compliance.
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