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QA Specialist - Boston MA - 14803

Boston , MA 02210

Posted: 04/06/2022 Industry: Scientific and Life Sciences Job Number: 14219

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: QA Specialist

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: 6 mos, possibility to extend
  • Pay rate: $28-40/hr
  • Job Location: Boston MA
  • Job#: bh14219

QA Specialist
 

The Operational Area Quality Specialist will provide QA support of analytical laboratory operations. This role will review data clinical and commercial analytical, release and stability data, including deviations, in-process data, and other quality systems documentation as needed in support of product disposition.

 

Key Duties and Responsibilities:

•           Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.

•           Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.

•           Upload the vendor created protocols in QDocs and update all commercial stability-controlled documents in QDoccs including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.

•           Provide support to Clinical analytical data review as needed

•           Support the day-to-day management of the analytical data from external CMO – Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.

•           Communicates proactively with internal and external partners and management.

•           Assists department mgmt. with monthly/quarterly Quality System data review metrics and reporting

•           Escalate critical and major finding to Quality management related to GXP Operational areas.

Knowledge and Skills:

•           Strong communication and influencing skills

•           Ability to evaluate quality matters and make decisions utilizing risk-based approach

•           Proficiency in using Microsoft Office applications

•           Some experience with quality metrics, dashboards, analysis, and improvement programs

•           Some experience with network-based applications such as Oracle, TrackWise, Veeva

•           Basic knowledge of current industry trends and could use the latest technologies

 

Education and Experience:

•           Bachelor's degree in relevant field is required

•           Typically requires 3-4 years of experience or the equivalent combination of education and experience

 

 

 

 


 

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!

Meet Your Recruiter

Alexandra (Scuncio) Pettit
Team Lead, Sr. Technical Recruiter

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