Technical Writer - Biologics Manufacturing, San Diego, CA

Technical Writer - Biologics Manufacturing, San Diego, CA

Overall Responsibilities:
The Technical Writer will work with Process Development (PD), Manufacturing Science and Technology (MSAT), and Manufacturing (MFG) Subject Matter Expert (SMEs) to prepare new or revise existing Batch Records (BR’s), Standard Operations Procedures (SOPs), and policies as part of an overall document coordination and project integration in company's Contract Development Manufacturing Organization (CDMO). This role will implement the document workflow process as a formal written procedure as well as being responsible for supporting the development and revision of procedures by applying document standards, criteria and adhering to timelines. The writer will also address policies revolving around drug safety, Quality Assurance, and Regulatory Affairs guidelines. The technical writer will assist in deviation report writing based upon documentation and operational discrepancies.

Position Responsibilities: 

  • Develop SOPs and Batch Records and ensure cGMP alignment with 21 CFR and ICH guidelines. • Asist in developing Operation on boarding program and training program. 
  • Assist in developing departmental guidelines and policies. 
  • Supports the full procedural document lifecycle for Policies, SOPs, BRs and Specification Forms by serving as a Technical Writer. 
  • Collects input from stakeholders and consolidate comments, resolving conflicts collaboratively. 
  • Works with MSAT and MFG process owner and SMEs to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across documents. 
  • Translates process maps or other process representations and applies them to SOP procedure wording. 
  • Works with functional area SME to develop cross-functional process models. 
  • Contributes to the development and maintenance of up-to-date SOP Writer procedures so that the process is used and consistently applied by all SOP writers. 
  • Contributes to the maintenance and updates to SOPs, coordinating tracking spreadsheets and timelines, as assigned. 
  • Displays the ability to manage customer expectations. 
  • Demonstrates proactive thinking and actions. 
  • Familiar with cross-functional customer service techniques. 
  • Ability to multi-task in fast-moving environment.

General Responsibilities: 

  • Operates to the highest ethical and moral standards. 
  • Complies with company policies and procedures. 
  • Adheres to quality standards set by regulations and company policies, procedures and mission. 
  • Communicates effectively with supervisors, colleagues and staff. 
  • Ability to participate effectively as a team player in all aspects of company business. 
  • Travels as needed between sites and to attend professional conferences and train on new technologies
  • Note: This position summary is not intended to be all-inclusive. Employee may perform other related duties as directed to meet the ongoing needs of the organization.

Qualifications/Skills Required: 

  • Bachelor’s degree in scientific or life science field. 
  • At least 3 to 5 years of process development or manufacturing procedural writing experience in the Biotech or Pharmaceutical, or relevant comparable industry. 
  • Experience working in a GXP environment with emphasis on GMP. 
  • QA and Training experience a plus.

For Immediate Consideration, Apply Today! Questions? Call Alex at 858.207.6311 for More Info.

Why Kelly®?

Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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