Position Summary: Responsible for all production specific to the Calibrator and Control Lab while working under current GMPs.

Essential Job Functions:

•        Maintains the lab areas in full GMP compliance.

•        Orders and/or prepares all reagents/materials for performing procedures and maintains adequate and accurate inventory of all components.

•        Performs assay testing on various chemistry analyzers.

•        Maintains records in accordance with Fujirebio Diagnostics, Inc.’s policies and applicable government regulations.

•        Verifies that all batch records, SOPs, and specifications are up-to-date and reflect the current procedure.

•        Through cross training, aids in other operations as requested.

•        Assures that all operations are performed according to SOPs and procedures. Any deviations from procedure must be communicated immediately to Supervisor.

•        Provides documentation on training on the proper use of appropriate batch records, SOPs, 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, segregated, and clearly identified.

•        Disposes of damaged, rejected, or residual components/products according to SOPs.

•        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.

•        Responsible for the manufacture of all calibrators, controls, standards, reference sets, panels and all other liquid components which make up the finished components for kits according to the device master record and MES electronic batch records.

•        Responsible for the aseptic filtration of all liquid components according to the device master record and POMS/Aquila electronic batch records.

•        Responsible for the processing of human plasma/serum and whole blood while using Universal Blood Precautions.

•        Performs all testing on incoming materials according to the device master record and POMS/Aquila electronic batch records.

•        Performs validation/qualification work in accordance with Fujirebio policies and applicable GMPs.

•        May support other areas of Primary Manufacturing.

•        Follows all company environmental, health and safety policies, procedures, and guidelines, and conducts work in a safe manner.

•        Performs other duties as assigned.

Job Specifications (skills, knowledge, special training, certification, license requirements):

•        Familiarity with the following equipment:

  •        Mixers

  •        Laminar Flow Hoods

  •        Centrifuges

  •        Balances

  •        Filtration Apparatus

  •        Vacuum Pumps

  •        pH Meters

  •        Chemistry Analyzers

  •        Spectrophotometer

  •        Heat Sealer

•        Use of respirator may be required

•        Understands and practices aseptic techniques

•        Understands and follows MES recipe and navigates through POMS/Aquila electronic batch records

•        Ability to work with large quantities of human serum/plasma and whole blood

•        Ability to lift 30 lbs.

•        Proficient PC skills

•        Ability to interact with all levels of staff

•        Ability to work in a high pressured and deadline-oriented environment

•        Excellent attention-to-detail, communication skills, and multitasking

•        Excellent attendance required

Education and Work Experience Required:

•        High School Diploma or equivalent required; college degree preferred

•        Previous experience in the medical device/pharmaceutical industry with knowledge of lab equipment preferred

•        Knowledge of GMPs, SOPs, and batch records

The base salary range for this position is $55,000- $65,000/year.  The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

We offer a competitive benefits package that starts on day one, including medical, employer-paid dental & vision, 401(k) match up to 5%, and generous PTO and holiday benefits.  The typical work schedule consists of 4 ten-hour shifts per week (Monday to Thursday).

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer