Laboratory Operations Core

is seeking to hire a Quality Assurance Specialist for our client in Rocklin CA.
Benefits Available.
Weekly Pay.
$25.00/Hour
Description:
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
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.