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22 days old

Technical Writer, Biologics

Kelly Services
San Diego, CA 92108
  • Jobs Rated
    43rd
**Technical Writer, Biologics, San Diego, CA**

If you have a background in cell-culture or purification (upstream or downstream) and hands-on experiencing generating batch records and technical writing, apply today for immediate consideration!


**Position Type:** Temp with possibility to hire

Work Schedule: Onsite required, M-F


**Overall Responsibilities:**


The Technical Writer will prepare new or revise existing Batch Records (BRs), Standard Operations Procedures (SOPs), and policies as part of an overall document coordination and project integration in 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.

+ 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.


**Qualifications/Skills Required:**


+ Bachelors 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.


_Fast track the process and apply today! Qualified talent will be contacted within 24 hrs._


**If youre unable to apply through the website, please email your resume in Word format and position title to JEND557@kellyscientific.com.**


Kelly Science & Clinical is the premier destination for Scientific Professionals seeking Direct-Hire, Temp-to-Hire, and Contract positions across the country. Scientific Recruiters are ready to select and represent the best candidates to join their award winning scientific clients.


\#TJP2021_SPEC


**Why Kelly** **** **?**


Kelly Science & Clinical 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Jobs Rated Reports for Technical Writer

Posted: 2021-03-29 Expires: 2021-05-01

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Technical Writer, Biologics

Kelly Services
San Diego, CA 92108

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Technical Writer
43rd2019 - Technical Writer
Overall Rating: 43/199
Median Salary: $71,815

Work Environment
Very Good
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Stress
Medium
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Growth
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