Quality Assurance Specialist Job at Proclinical Staffing, Cambridge, MA

cEdCbHJ2Z1RBTitacTBlQm4xSmhaUlJZaGc9PQ==
  • 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

W.R. Berkley

IT Security Engineer Job at W.R. Berkley

 ...Services: Right Team, Right Technology, Simple and Secure. Responsibilities The Information Security Engineer is responsible for implementing and managing a...  ...collaboration skills. Certifications such as CISSP, CISM, Azure Security Engineer, or similar, are a plus. BS... 

MARYHAVEN,INC

Detox Counselor Assistant/Case Manager (CDCA) Job at MARYHAVEN,INC

 ...Detox Counselor Assistant/Case Manager Requirements Masters, Bachelors, or Associates degree in human service or behavioral science...  ...commensurate with experience. ~ Medical, vision, and dental insurance effective on your first day!~ Paid time off (PTO) starts accruing... 

Industrial Roofing & Construction

Metal Roofing Installers Job at Industrial Roofing & Construction

 ...work, competitive pricing, and a focus on safety. Role Description This is a full-time remote role for Metal Roofing Installers. The Metal Roofing Installers will be responsible for carpentry, insulation, working at heights, roofs, and waterproofing tasks related... 

Dan Newlin Injury Attorneys

Mail Clerk Job at Dan Newlin Injury Attorneys

 ...Maintain record of incoming mail but entering notes in the software system Ensure delivery of outgoing mail to courier and post office Count and record inventory items Assist in archiving documents Perform data entry activities Post shipping labels on... 

Ultimate Staffing

Office Clerk with MS Excel skills Job at Ultimate Staffing

 ...Job Description : We are seeking an organized, detail-oriented, and motivated Office Clerk with a strong proficiency in Microsoft Excel to join our team. The ideal candidate will be responsible for performing various administrative and clerical tasks to support the...