Job Description

WE ARE SEEKING A QUALITY ASSURANCE TECHNICAL WRITER TO JOIN OUR TEAM! JOIN A GROWING SAN DIEGO-BASED COMPANY THAT IS PIONEERING THE PRODUCTION OF SEAFOOD PRODUCTS DERIVED DIRECTLY FROM FISH CELLS. USING PROPRIETARY CELL BIOLOGY TECHNIQUES AND ENGINEERING PROCESSES THAT PRODUCE A WIDE ARRAY OF VALUE-ADDED SEAFOOD PRODUCTS, THAT ARE HEALTHY FOR PEOPLE, HUMANE FOR SEA LIFE, AND SUSTAINABLE FOR OUR PLANET.

JOB SUMMARY:

The Quality Assurance Technical Writer will author documentation including Specifications, Standard Operating Procedures (SOP) and Master Batch Records (MBR) for the manufacture of cell-based seafood products in accordance with Current Good Manufacturing Practices (cGMP’s). This individual will work cross-functionally with R&D, Bioprocess Engineering, Quality and other functional areas as needed to ensure timely completion of operations and quality related documentation in accordance with project plans and timelines. This individual will be a vital member of the Quality team and report to the Director of Quality Assurance and Regulatory Affairs or the Quality Assurance Manager.

JOB RESPONSIBILITIES:

• Analyze upstream and downstream processes and make recommendations for efficient and effective supporting document structure.
• Collaborate with area managers to develop and refine document project plan and timing.
• Work with departments to gather technical input required to generate new and revise existing documents following document control procedures and in accordance 21 CFR 117, 21 CFR 123, and SQF requirements.
• Work on technical writing assignments that are complex in nature where action and a high degree of initiative are required to resolve challenges associated with new processes and make recommendations.
• Write and edit all types of documentation produced within a GMP environment required for the production of cell-based seafood products including but not limited to:
  • Raw material and finished product specifications
  • Test and inspection methods
  • Standard operating procedures
  • Manufacturing work instructions
  • Master batch records
  • Qualification protocols and reports
• Track documentation project deliverables and manage to timelines
• Provide training related to documents generated, as needed
• Assist in documentation audits and publish audit reports
• Assist QA management with special projects or other duties as assigned

REQUIRED SKILLS:

• Demonstrated technical writing skills with the ability to create clear and concise written instructions and intuitive recording forms.
• Practical knowledge of FDA regulations including GMP and GDP.
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
• Strong proficiency with computer systems, including eQMS system, and MS Office suite, particularly Word, Excel, and PowerPoint.
• Strong organization skills, with the ability to organize, plan, prioritize work, and manage multiple projects effectively, within agreed upon timelines.
• Strong interpersonal skills, with the ability to positively interface with individuals at all levels of the organization.
• Strong communication skills, including written, verbal, and presentation.
• Strong team orientation, with the ability to self-start, as well as work independently.
• Strong attention to detail with the ability to perform tasks with a high degree of accuracy.

QUALIFICATIONS & EXPERIENCE:

• Knowledge of science generally obtained through Associates or 4-Year degree in life science related discipline is preferred.
• A minimum of 5+ years process operations experience in a manufacturing facility subject to GMP regulations with at least one year experience with technical writing.
• Experience generating quality system and operations related documentation in a GMP environment.
• Expertise with Microsoft Word, Excel, Adobe Acrobat, and PowerPoint, to perform critical job functions.
• Experience with cell culture strongly preferred.