Category: Scientific & Clinical
Title: GMP Compliance Specialist - Deviations
Location: Rockville, MD
Schedule: 9AM-5PM (overtime as needed)
Start Date: Immediate
Joule is seeking a Deviations Investigation Specialist for an innovative Biotech Company located in Rockville, MD!
- Ensure deviations, investigations, CAPAs, and Change Contols 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
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.