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12 days old

Quality Assurance - Biopharmaceutical

Kelly Services
Summit, NJ 07901
Kelly Science and Clinical FSP is currently seeking a Quality Assurance/Manufacturing Senior Technical Writer for a long-term engagement with one of our Global Biopharmaceutical clients. This position is onsite in Summit, NJ. 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, Vision, 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.



**PURPOSE** **AND SCOPE OF POSITION:**


Manufacturing Senior Technical Writers 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 for 2 CAR T products. The Senior Technical 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 Senior Technical writer will write, revise, and review all related GMP documentation for S12 CAR T manufacturing operations including SOPs, Batch Records, and Work Instructions.


**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


**Education and Experience:**


Masters degree plus 2 years of experience in Manufacturing Technical Writing or in a QA role


OR Bachelors degree plus 5-7 years of experience in Manufacturing Technical 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


**DUTIES AND RESPONSIBILITIES:**


+ 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 in S12

+ 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


**WORKING CONDITIONS (US Only):**


+ 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.


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.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-27

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Quality Assurance - Biopharmaceutical

Kelly Services
Summit, NJ 07901

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