Quality Control Analyst II

  • location: Framingham, MA
  • type: Contract
  • salary: $28.18 - $33.15 per hour
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job description

Quality Control Analyst II

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: Framingham, Massachusetts
job type: Contract
salary: $28.18 - 33.15 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the Manufacturing Facility.
  • The department performs analytical testing on intermediate, inprocess and final product materials using a variety of equipment to include GC, FTIR, UVVIS, and physical property instrumentation.
  • Perform Assays in accordance with SOP's for release, stability and in-process samples.
  • Review peer data including data transcription, data calculation and log entries.
  • Initiate DCR's as required. Manage Periodic review program for group.
  • Train on all documents assigned to training plan.
  • Perform or participate in Equipment Qualifications.
  • Support Method Validations.
  • Complete training as assigned.
  • Author technical reports.
  • Bring in new equipment (spec, URS, etc.).
  • Conduct department walkthroughs.
  • Review and approve control trends.
  • Schedule coordinator.
  • Complete effectiveness reviews.
  • CAPA plans, assignments, closure.
  • Maintain deviation/CAPA/Task/CCR database to help drive closure.
  • Investigate Deviations.
  • Attend Deviation Meetings.
  • Responsible for adherence to policies, procedures and SOP's.
  • Participate and approve lab investigations.
  • Adhere to site Quality and Safety Policies.
  • Work toward accomplishment of Site Goals.
  • Perform OOS investigations.
  • Participate in audits.
  • Create/review Certificates of Analysis
 
qualifications:
  • Bachelor's degree or equivalent in science.
  • Experience in laboratory techniques such as: pH, GC, UV/VIS and FTIR.
  • Technical writing and Assay validation experience.
  • Technical experience in problem solving analytical methods and strong attention to details
  • 5-8 years lab experience.
 
skills: Quality control, SOP, GMP (Good Manufacturing Practice)
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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