Quality Control Scientist III

  • location: Waltham, MA
  • type: Contract
  • salary: $39.47 - $46.44 per hour
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job description

Quality Control Scientist III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Waltham, Massachusetts
job type: Contract
salary: $39.47 - 46.44 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Manage contract Laboratory Testing for release analysis and stability testing
  • Handle the samples shipment from CMO to CLO ability
  • Maintains relationships with CLO's per QTA
  • Support CLO for lab investigation
  • Oversee testing programs including: Assay Controls, Reference Standards, Product Release, Stability
  • Oversees budgeting for CLO's; including contracts and purchase orders
  • Responsible for external quality testing at CLO's (including in-process, release, and stability); ensures complete documentation for compliance with cGMPs
  • Maintains relationships with CLO's to ensure Quality Agreements, Statement of Work (SOW), and Manufacturing Service Agreements (MSA) are initiated and updated accordingly
  • Oversee testing programs including: Assay Controls, Reference Standards, Product Release, Stability
  • Oversees budgeting for CLO's; including contracts and purchase orders
  • Support and facilitate deviations and investigations
  • Support long-term planning of QC lab capabilities and capacity
  • Responsible for coordinating with AD for the implementation of new technologies into CLO network
  • Change notification management
  • Data entry into LIMS
  • Data analysis for release data
  • Coordination and drafting of Annual Product Review sections
  • Coordination of Annual Method Reviews
  • Coordination/review of compendial methods for compliance
  • Active participant in the management and direction of the overall QC programs and requirements
 
qualifications:
  • BS/MS in a scientific discipline
  • Minimum of 10 years experience in a GMP regulated industry (e.g. pharmaceutical or biotechnology).
  • Experience managing contract laboratory organizations (CLO's) preferred.
 
skills: Quality control, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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