Category: Scientific & Clinical
Title: Deviation Specialist
Location: Rockville, MD
Type: 9+ month contract with possible hire
Schedule: 9AM-5PM (overtime as needed)
Start Date: Immediate
Innovative Life Sciences Company is currently hiring for a Deviation Specialist to manage and resolve noncomformities relating to manufacturing, technical operations, and quality control.
- Ensure deviations, CAPAs, and CCs are timely addressed and closed
- Work closely with department subject matter experts to obtain pertinent information necessary to write/close deviations
- Provide expertise on necessary preventative measures and ensure deviation metrics are in a controlled state
- Act as SME for defending relevant deviations in GMP audits (internal and external).
- Lead and coordinate efforts for continuous improvement in deviation reduction and manufacturing operations for the site.
- Author and resolve Deviations, Change Controls, CAPAs and additional documents to support production needs and meet product release requirements.
- Utilize root cause analysis tools and work cross functionally to implement effective CAPAs.
- Interview personnel involved to determine true root cause
- Write CAPAs & CCs to meet production release requirements, support continuous improvement efforts and operational optimization.
- Write, review, revise and/or prepare documents (BPRs, RPTs, SOPs, SWIs, etc.) in accordance with cGMPs and regulatory guidelines.
- Compile and report performance metrics for quality systems.
- Bachelor's Degree in Science
- 4+ years of technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry
- Experience with FDA audit ready initiatives
- Effectively and expertly write technical deviations relating to manufacturing process and review documents with thorough understanding of the biopharmaceutical manufacturing process, GMPs, CAPAs and regulatory guidelines
- Working knowledge of root cause analysis tools and continuous improvement techniques
- Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report
For immediate consideration please send resumes to Gina at firstname.lastname@example.org