Hiring company: Gilead
Technical Writer, Manufacturing
Overview
We are seeking a Technical Writer to support our clinical manufacturing facility in Oceanside, CA that includes GMP areas for bioprocessing. Under minimal supervision, this position is accountable for technical writing deliverables in support of manufacturing operations while closely collaborating with Quality Assurance (QA), Engineering, Quality Control (QC), and Technical Operations (TO).
Responsibilities (include but are not limited to):
Perform all tasks associated with Quality Systems Record Management
Deviation ownership - In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
CAPA ownership - Devises and implements Corrective and Preventative Actions to address root cause and ensure effectiveness collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents as support is needed
Change Management ownership – Initiate necessary changes resulting from corrective actions.
General operational excellence changes to GMP documents (batch records, SOPs, forms, use logs, etc.)
Support Manufacturing and collaborate with Technical Operations, Quality Assurance, Quality Control, Supply Chain and Facilities on assigned tasks.
Execute and collaborate with manufacturing on Human Error Reduction and Right First Time Initiatives.
Maintain Quality Record/Tech Writing Team metrics, identify and support improvement efforts with Tech Writer Lead.
Maintain on-time completion of all required training.
Maintain gowning certification.
Other tasks and duties as assigned by Management.
Basic Qualifications:
Master’s degree with 2+ years or a Bachelor’s degree with 4+ years of experience in science/engineering, manufacturing and quality in biotech/pharma industry or an AA degree with 5+ years of experience in science/engineering, manufacturing and quality in biotech/pharma industry or a High School degree with 6+ years of experience in science/engineering, manufacturing and quality in biotech/pharma industry
Preferred Qualifications:
Cell culture and/or Purification bioprocess experience.
Broad technical knowledge of cGMP compliance and experience with leading investigations, authoring deviation reports, change management, and corrective actions.
Experience with investigation and root cause analysis tools (Pareto, 5-Why’s, Fishbone diagram, Failure Mode and Effects Analysis etc.).
Experience with creating and delivering presentations.
Proficiency in using Microsoft Word, Excel, and Project.
Utilizes technical writing strategies to ensure content is clear and concise.
Possesses good verbal communication skills.
Ability to think critically, with demonstrated troubleshooting and problem-solving skills. Takes initiative in solving issues.
Strong understanding of the Manufacturing Process.
Ability to support shift work and potential overtime
* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue.
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.