QA Investigations Writer

KVK Tech is looking for a QA Investigations Writer to join our team in Newtown, PA.

The QA Investigations Writer’s 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.

This position’s responsibilities will include, but not be limited to the following:

• 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.
• Reviews and uses the established follow up mechanism to ensure that applicable investigations are initiated, timely completed, final reports issued and approved by QA.
• 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.
• 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.
• Maintains an updated knowledge of the cGMP regulations and FDA Guidelines and utilizes those principles in the investigation process and final report issuance.
• Issue investigation reports, complaints follow-up and applicable monthly monitoring progress reports for the site.

Benefits Include:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays

We are looking for applicants with:

• Strong technical writing skills
• Technical knowledge in pharmaceutical manufacturing processes, technologies, process validation and processing equipment
• Proficiency in handling concurrently and effectively multiple high-priority initiatives with evident sense of urgency and sound quality-minded approach
• Proficiency in the use of Personal Computers, including knowledge of word processing, Power Point type presentations, spreadsheets, database and electronic mail applications.

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.