Job Details
Job Title: Production Lab Technician
Job Location: Rocklin, CA
Job Duration: 12 Months
Pay Range: $25/hr. on W2
Primary Objective of Position:
Under supervision, the Production Lab Tech - Mfg Histology performs laboratory activities in the manufacturing lab including slide manufacturing events and packaging events and assists in tasks required for block qualification; follows the manufacturing schedule to complete required tasks per standard operating procedures involving basic laboratory techniques, calculations, material measurements, operation of laboratory equipment and record keeping as necessary.
Essential Functions:
Manufacture and package products following SOPs.
Use local ERP systems to accurately document manufacturing processes.
Stock area inventories as necessary.
Maintain lab cleanliness and comply with cGMP compliance.
Perform microtomy, IHC staining, and troubleshoot.
Maintain records and keep spreadsheets updated.
Escalate any non-conforming products to management, participate in the investigation process.
Meet productivity standards and strive to increase productivity without sacrificing quality and safety.
Look for ways to improve and promote quality.
Demonstrate accuracy and thoroughness.
Manage time and priorities to meet deadlines.
Troubleshoot equipment problems.
Work on various projects to improve efficiency or compliance.
Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.
Other duties as assigned or required by the business.
Education & Experience:
AA/AS in a biological science or biochemistry field with 1 year of production experience OR high school diploma/GED and 3 years lab experience in a related discipline which supports performance of required tasks in a final production role.
Knowledge of FDA QSRs and ISO 13485 or other related industry standards preferred; experience with SAP or other ERP system is strongly preferred.
Previous experience in FDA regulated biotechnology or pharmaceutical environment is strongly preferred.