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Technical Writer - Scientific

Kelly Services

Englewood, CO
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Technical Writer - Scientific

Jobid US15TPCS_BH1425881

Location: Englewood, CO, 80113, USA

Description **Operations Technical Writer 60-80 K per year**

**Job Purpose and Function:**

Responsible for writing technical documentation for operations including procedures, deviations, change controls, corrective and preventative action (CAPA) plans, standard operating procedures (SOP), records, qualification/validation packages and studies. Works with Quality Assurance to ensure the formatting, requirements and approval of controlled documents is performed in a timely manner to meet production goals. A certain degree of creativity and latitude is required.

**Primary tasks include:**

+ Formatting and general review of documents to ensure they meet the requirements in the SOP procedure
+ Writing of master records (SOPs, BPRs, deviations, CAPAs, change controls, WI, QR, etc.) for production
+ Interviewing operations personnel to define processes, procedures, and workflows
+ Interface and collaborate with cross-functional departments to fully understand products, procedures and processes as well as equipment/machinery to develop SOPs for production departments (production, engineering, maintenance, shipping/receiving, etc.)
+ Create Technical Writing documents regarding current Good Manufacturing Practices
+ Ensure accuracy by reviewing documents for completeness and proper authorization for approvals
+ Coordinate revisions, reviews and approvals for operations
+ Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements
+ Analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
+ Works with Quality Assurance to ensure controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
+ Maintain extensive knowledge of product information and continuous contacts with team members
+ May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
Other tasks and responsibilities include:

+ Performs operations review of batch records and other operational documents prior to quality assurance review
+ Work with operations and regulatory group to prepare CMC sections for BLA submission
+ Other duties as required
**Key Skills Required:**

Requires a minimum of a bachelor's degree in Microbiology, Biological Sciences, Chemistry or relevant area with 2-4 years of experience in biotechnology/pharmaceutical industry (or related, regulated field). Direct experience in a GMP manufacturing environment. Relies on limited experience and judgment to plan and accomplish goals.

Specific work experience in creating regulated technical documents. Ability to use MS Word, MS Excel and other document applications. Must be able to provide advanced formatting for controlled documents.

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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