Primary Manufacturing Technician- Cals/Controls

Fujirebio; Malvern (Chester County); On-site; USD 55,000 - 65,000; Full time

Job summary

Fujirebio Diagnostics, Inc. in the United States is seeking a Lab Technician to manage all production for calibrators and controls in a GMP environment. The role focuses on preparing reagents, maintaining inventory, and performing assay testing using chemistry analyzers.

The ideal candidate will have a high school diploma (college degree preferred) and experience with GMPs, SOPs, and batch records. The position requires adherence to safety standards and the ability to work under deadline

Qualifications

• High School Diploma or equivalent; college degree preferred.
• Experience in medical device/pharmaceutical industry with lab equipment knowledge helpful.
• Knowledge of GMPs, SOPs, and batch records.

Responsibilities

• Maintain GMP-compliant lab areas.
• Prepare reagents/materials and manage inventory.
• Perform assay testing on chemistry analyzers.
• Maintain batch records and SOP compliance.
• Cross-train and assist other operations as needed.
• Ensure safety and proper calibration/maintenance of equipment.

Skills

Aseptic techniques

Attention to detail

Multitasking

Communication

Team collaboration

Education

High School Diploma

College degree preferred

Tools

Mixers

Laminar Flow Hoods

Centrifuges

Balances

Filtration Apparatus

Vacuum Pumps

pH Meters

Chemistry Analyzers

Spectrophotometer

Heat Sealer

Job description

About Us

For 75 years, Fujirebio Diagnostics Inc., is a leading worldwide biotechnology Company and the innovation engine behind diagnostic breakthroughs that reach patients worldwide. Our in vitro diagnostics (IVD) technology powers critical tests across the globe’s leading diagnostic platforms. We are a biomarker and diagnostic content provider that strengthens diagnostics for everyone. Through our approach of innovation, clinical evidence and global CDMO partnerships, we ensure that next-generation biomarkers are accessible across diagnostic platforms, so patients benefit no matter which system is used.

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

Benefits and Compensation

We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement.

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.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer