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Associate II, Clinical Quality Assurance

Bedford, MA 01803

Posted: 04/12/2022 Industry: Scientific and Life Sciences Job Number: 14249

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: Associate II, Clinical Quality Assurance

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Temp to Perm
  • Pay rate: $31/hr
  • Job Location: Bedford, MA
  • Job#: bh14249

 

Associate II, Clinical Quality Assurance

The Role:

Seeking a Quality Assurance Associate II for support and oversight of internal Clinical Manufacturing. This position will be based in, MA.

The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early-stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical, and Process Development Technology Transfer counterparts. This position will be 1st shift from 7:00 am to 5:00 pm Wednesday to Saturday.

Here’s What You’ll Do:

  • Participate in quality-focused teams across a broad ecosystem of functions.
  • Authors and reviews SOPs, policies, and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
  • Oversee and review executed electronic and paper batch record documentation.
  • Develop batch records, SOPs, and training materials for the startup of the Norwood Facility
  • Reviews minor manufacturing deviations.
  • Closely partner with peers for disposition of Plasmid, Drug Substance, and Drug Product
  • Demonstrate general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
  • Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions and process data.
  • Monitor process operations to ensure compliance with specifications.
  • Practice safe work habits and adhere to safety procedures and guidelines.
  • Utilize knowledge to improve operational efficiency.
  • Participate in quality oversite of manufacturing through real-time observations of activities.

 

Here’s What You’ll Bring to the Table:

  • At least 2-4 years of experience in a GMP manufacturing environment with a bachelor’s degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry, or related field

Candidates should be aware that we currently maintain a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted before their employment start date. An equal opportunity employer will provide reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

 

 

 

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!

 

*MON

 

Meet Your Recruiter

Emily Donahue
Regional Recruiting Manager

  • Directthe recruitment efforts for both the Quincy, MA and Providence, RI branches. 
  • Manages a distributed team of recruiting leads, individual contributor recruiters and account managers. 
  • Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region. 
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