Quality Assurance Specialist Job at Proclinical Staffing, Cambridge, MA

U05mSnM0SnpyRTk3bE9VRFJHaEswb0tQcXc9PQ==
  • Proclinical Staffing
  • Cambridge, MA

Job Description

Quality Assurance Specialist - Contract - Cambridge, MA

Proclinical is working alongside a pharmaceutical company seeking a Quality Assurance Specialist to join their team.

Primary Responsibilities:

The successful candidate will play a pivotal role in managing activities within a GMP-regulated environment, ensuring adherence to cGMPs and regulatory standards throughout the product development lifecycle. This position offers an exciting opportunity to work with cutting-edge cell therapies in the oncology sector.

Skills & Requirements:

  • Bachelor's degree in biology, Microbiology, Chemistry, or related field.
  • Experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy manufacturing.
  • Knowledge of current GMP regulations in pharmaceuticals and cell/gene therapies.
  • Understanding of Quality Management Systems and ability to make informed decisions.
  • Local travel between manufacturing sites is required.

The Quality Assurance Specialist's responsibilities will be:

  • Issue, review, and approve GMP documentation such as batch records and SOPs.
  • Review and reconcile logbooks and documentation.
  • Assist in walkthroughs with senior Quality staff.
  • Review labeling and packaging batch records for release preparation.
  • Evaluate work orders, equipment qualification, and validation documentation.
  • Ensure compliance and accuracy in batch record documentation for drug substance/product release.
  • Provide daily onsite quality oversight and guidance, collaborating across functions.
  • Represent QA in operations from starting material thaw to product filling and labeling.
  • Perform additional duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

Job Tags

Contract work, Local area,

Similar Jobs

Vitalia - Westlake

Server 4pm-7:30pm $15-$17 (Part-Time) Job at Vitalia - Westlake

 ...Team MemberPosition-ServerPosition Type: Part-TimeLocation: Westlake, OhioOur starting wage for Servers is: $15.00-$17.00 per hour!Shift Schedule-Sunday, Monday, Tuesday 4pm-7:30pmCome join our team at Vitalia Senior Residences at Westlake located at... 

Chevrolet of Montebello

Internet Sales Manager Job at Chevrolet of Montebello

 ...Do you want to work at one of the busiest automotive dealerships in the region where your employer treats you like a member of the family...  ...booming. We are hiring additional Automotive Experienced Internet Sales Associates to accommodate the increase in customer traffic, in... 

JOURNEYS WITH JP

Remote Travel Consultant Job at JOURNEYS WITH JP

Travel Enthusiast? Turn Your Passion into a Profitable Career! Become a Remote Travel Consultant Are you a seasoned traveler or simply a passionate explorer? Want to turn your love for adventure into a fulfilling career? Join our team of Remote Travel Consultants... 

CyberCoders

Estimator Job at CyberCoders

 ...Estimator-Roofing Position Overview The Estimator-Roofing is responsible for accurately assessing and estimating the costs of...  ...project information. Utilize estimating software such as Xactimate and Procore to create and manage estimates. Conduct site... 

Waterfall Community Health Center

General Dentist Job at Waterfall Community Health Center

 ...Critical Illness, Accident, and Hospital Indemnity coverage is available ~ Employee Assistance Program (EAP)~ Downtown Health and Fitness gym membership discount ~ Bonusly Internal Employee Recognition Platform ~ Headspace care employer paid membership...