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location: Framingham, Massachusetts
job type: Contract
salary: $28.18 - 33.15 per hour
work hours: 9 to 5
- 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
- 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.