Job Description

QUALITY ASSURANCE TECHNICAL WRITER - TALENTZOK

OVERVIEW

Are you looking for a new career opportunity with an exciting company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Quality Assurance Technical Writer at our client, an ‘essential business', located in San Diego, CA who possess:

• 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.

Email resumes to sdinfo@talentzok.com or call 858.800.3050

FULL DESCRIPTION: 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.

The selected candidate will further possess:

• 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.

The selected candidate will be responsible for the following:

• 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 company 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:
  1. Raw material and finished product specifications
  2. Test and inspection methods
  3. Standard operating procedures
  4. Manufacturing work instructions
  5. Master batch records
  6. 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

For immediate and confidential consideration, please email your resume to sdinfo@talentzok.com or call 858.800.3050

More information can be found at www.TalentZok.com

Company Description

IT'S ALL WE DO. We believe that effective and successful recruiting must be specialized, both in industry and geography. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. THE INSIDER'S NETWORK When you register with us, we plug you into an existing network of companies that don’t always post to job boards. You will have access to unique opportunities throughout the greater Los Angeles area - opportunities you won’t find on your own. THANK YOU FOR CALLING We’ve picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? How many recruiting firms have you sent your resume to who haven’t called you back promptly? At TalentZök, customer service is our priority. We return calls promptly. We don’t let you fall through the cracks. It sounds so simple yet so few know how to do it right. THE IMPORTANCE OF A FIRM HANDSHAKE There is no substitute for meeting someone in person. It is the only way to really understand people. We interview all of our candidates in person before they interview at our client companies to ensure the best possible fit. We also visit companies in person, meet the people involved in the decision, get a feel for the company culture and get a thorough understanding of the job. We won’t waste your time because we’re committed to understanding exactly what it is you’re looking for.