1+ months

Deviation andInvestigation Quality Technical Writer

Kelly Services
Summit, NJ 07901
  • Jobs Rated
**Deviation and Investigation Quality Technical Writer**

**Summit, NJ**

Kelly Services is currently seeking a Deviation Investigation Technical Writer for a long-term engagement with one of our Global Pharmaceutical clients in Summit New Jersey

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

**Duties and Responsibilities:** Manufacturing QA Deviation Investigation Writer work cross-functionally with Manufacturing, MS&T, and Quality groups to lead MO deviation investigations, and author/revise GMP documentation to support clinical and commercial lot release. The QA Deviation Investigation Writer will also be responsible for working with the MO and QA teams to agree on appropriate CAPAs as needed and ensure on time implementation and closure of actions. The QA Deviation Investigation Writer will write, revise, and review all related GMP documentation for manufacturing operations including SOPs, Batch Records, and Work Instructions.

+ Lead Manufacturing NOEs and deviation investigations to ensure on time closure

+ Responsible for opening change controls as needed to revise Batch Records, SOPs, Work Instructions to support new product/process implementation, and close CAPAs

+ Participate in cross-functional deviation and CAPA meetings and initiatives

+ Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to appropriately assign deviation investigations and CAPAs, and support closure

+ Serve as a credible SME as needed during audits to present and defend deviation investigations

+ Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations

+ Other duties may be assigned, as necessary

**Required Competencies: (Knowledge, Skills, and Abilities)**

+ Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products

+ Knowledge of cGMP/FDA regulated industry

+ Basic mathematical skills

+ Strong technical and compliance writing capability

+ Proficient in MS Office applications

+ Background to include an understanding of biology, chemistry, medical or clinical practices

+ Previous experience leading and closing deviation investigations to support lot release

**Working Conditions:**

+ Required to be onsite 2-3 days a week

+ Primarily office based, but some on floor/clean room interactions may be required.

+ Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.

+ Reagents, chemicals, and exposure to sanitization agents could be expected.

+ Potential exposure to human blood components and strong magnets.

+ Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum.

**Education and Experience:**

+ 5+ years experience within a QA Deviation Investigation Writing or Quality Assurance manufacturing role is required

+ Masters degree plus 2 years of experience in Manufacturing Deviation Investigation Writing or in a QA role

+ OR Bachelors degree plus 5-7 years of experience in Manufacturing Deviation Investigation Writing or in a QA role

+ OR Associate/ Medical Technical degree and 10 years of Manufacturing or Operations experience

+ OR High School diploma/GED and 15 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA

_This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job._

_This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management._

**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. (

Jobs Rated Reports for Technical Writer

Posted: 2021-08-16 Expires: 2021-11-08

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Deviation andInvestigation Quality Technical Writer

Kelly Services
Summit, NJ 07901

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

Work Environment
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