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Production Lab Technician
1 month ago
1 Year Contract
Rocklin, CA
PR: $20-25/hr
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:
- Associates or Bachelor’s degree in a biological science or biochemistry field with 1 year of production experience
- 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
Knowledge, Skills & Abilities:
- Good computer skills, including MS Office
- Good organizational skills and attention to detail
- Good verbal and written communication skills including the ability to create clear, concise, written reports and accurately complete batch records
- Knowledge of SAP NEXT strongly preferred
Physical and Environmental Requirements of Job: Must be able to perform the essential functions of the job listed below.
- Vision: Must be able to meet vision requirements as outlined by
- standard occupational guidelines.
- Lifting and Moving: Up to 25 lbs. per day
- Pushing: Occasionally up to twenty-five (25) pounds unassisted
- Sitting: Frequently as required by the process
- Standing: Frequently as required by the process
- Climbing: Occasionally, on ladder and/or step ladder, as required by the process
- Kneeling: Occasionally as required by the process
- Stooping: Occasionally as required by the process
- Full Use: Occasionally as required by the process
- Simultaneous: Occasionally as required by the process
- Communication: Job requires both written and oral skills in communicating with others
- and receiving instruction in English.
- Other: Repetitive motion with hands, fine manipulation - using fingers to push keys (keyboard) or pipetting in the laboratory; use of hands, reaching with hands and arms; occasional standing, and lifting; seldom will stoop or crouch.
Working Conditions: Must be able to perform the essential functions of the job.
- Much of the work will be in a production/manufacturing or laboratory environment. The ability to clearly and comfortably view, interpret and process information via a computer monitor for extended periods of time during normal working hours is required. The ability to work with moderate background noise is required.
