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Laboratory/Manufacturing Technician - Serum Processing

Fujirebio Diagnostics, Inc.

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Job Snapshot
Location:
201 Great Valley Parkway
Malvern, PA 19355 (map it!Map it! )
Employee Type:
Full-Time
Industry:
Biotechnology
Pharmaceutical
Manufacturing
Manages Others:
No
Job Type:
Biotech
Pharmaceutical
Manufacturing
Education:
High School
Experience:
At least 5 year(s)
Travel:
Negligible
Post Date:
10/26/2009
Contact Information
Phone:
610-240-3800
Ref ID:
2009-PMT-019
Description Fujirebio Diagnostics has an immediate opening for a Primary Manufacturing Technician. The qualified individual will be responsible for all production specific to the serum processing work area while working under current GMPs and, will be responsible for assisting in the processing of human plasma and the manufacturing of standards and controls.

 

Essential Job Functions include but are not limited to:

  • Responsible for the manufacture of all standards, controls and all other liquid components which make up the finished components for kits according to the device master record.
  • Responsible for performing RIA and EIA assays according to the device master record.
  • Responsible for the manufacturing of standards and controls according to the device master record.
  • Responsible for assisting in the processing of human and/or plasma and serum.
  • Understands and practices aseptic techniques.
  • Responsible for the aseptic filtration of all liquid components according to the device master record.
  • Responsible for the processing of human plasma/serum and whole blood while using Universal Blood Precautions.
  • Responsible for performing all testing on incoming materials according to the device master record.
  • Responsible for maintaining the lab areas in full GMP compliance.
  • Verifies that all batch records, SOP’s and specifications are up to date and reflect the current procedure.
  • Provides documentation on training on the proper use of appropriate batch records, SOP’s and specifications. Assures that all batch records are accurately completed.
  • Maintains all work areas in a clean and orderly state. Assures that products are stored and segregated and clearly identified.
  • Disposes of damaged, rejected or residual components/products according to SOP’s.
  • Identifies quality problems and reports product complaints (both internal and external) to supervisor.
  • Assures that all equipment is safe and all safety procedures are followed. Assures that all equipment is properly maintained, calibrated and validated prior to use.
    • Requirements Qualified candidate will have 5 plus years experience in the medical device/pharmaceutical industry; college degree or equivalent work experience required; excellent working knowledge of lab equipment; knowledge of GMP’s, SOP’s, radiation safety and batch records; ability to interact with all levels of staff; ability to lift 30 pounds; ability to work in a high pressured and deadline oriented environment; excellent communication skills; proficient PC skills; and excellent attendance required.
     
    We offer a competitive compensation and benefits package and a convenient Malvern location. EEO M/F/D/V
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