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1+ months

Technical Writer -production

Kelly Services
Canton, MA 02021
  • Jobs Rated
    43rd
Kelly Services is seeking a **Technical Writer -production** for a leading Pharmaceutical company located in **Canton, MA** .



please email me back at somp767@kellyservices.com (with your most up to date resume in word format) and advise the best time and number at which you can be reached.



**_Job Title:_** **Technical Writer -production**

**_Location:_** **Canton, MA, 02021 (ONSITE)**

**_Type: Contract_**

**_Length: 12 months_**

**_Pay rate: $90- $107 per hour (based on the experience)_**



**Note:** This will be a full-time position that is 100% onsite at Canton and would require the individual to remain on site due to current COVID related travel restrictions. We are looking to hire someone quickly This position will be to work on some old and the ever-growing new deviations that are opened daily.



**Job Description Summary**



Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of Product Discards, Field Actions, or Recalls. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.



**Job Description**




+ Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.

+ As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.

+ Prepares and analyzes manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to management.

+ The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.

+ The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.

+ Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.

+ Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.

+ Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems.

+ Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.

+ Perform any other tasks/duties as assigned by Manufacturing Management.



**Requirements**




+ BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.

+ At least three years experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports is also required. Must be familiar with regulatory (FDA) requirements.

+ Good deductive and inductive critical thinking skills required.

+ Advanced writing skills required.

+ Candidate must possess strong interpersonal, written, and verbal communication skills. Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments.

+ Proficient in MS Office programs, including Word and Excel.

+ Prefer candidates proficient with software programs TrackWise and Documentum.





Thanks

Soma Patanaik

Professional Technical Recruiter

Kelly Services, Inc

Somp767@kellyservices.com



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



By partnering with Kelly IT, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.




**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

Jobs Rated Reports for Technical Writer

Posted: 2020-12-16 Expires: 2021-02-15

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Technical Writer -production

Kelly Services
Canton, MA 02021

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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
93/220
Growth
Fair
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