Quality Control Expert 1

is seeking to hire a Quality Control Expert for our client in Rocklin, CA.
Pay rate: 23.00 - 25.00
Quality Control Technician
PRIMARY OBJECTIVE OF POSITION:
Under supervision, the Quality Control (QC) Technician performs laboratory activities in the QC lab
including inventory tracking, ordering maintenance, bio burden, slide filling, and IHC; completes required
tasks based on QC schedule needs and follows standard operating procedures (SOPs) involving basic
laboratory techniques, calculations, material measurements, operation of laboratory equipment and record
keeping as necessary; supports the day-to-day activities of the QC department while adhering to applicable
regulatory requirements, and local and global Quality Management System (QMS).
Essential Functions:

• Perform paperwork preparation, bioburden, and all basic laboratory tasks

• Track inventory levels and order materials as required

• Use local ERP system to accurately document work where required

• Stock area inventories on a daily, weekly, and monthly basis

• Maintain lab cleanliness in compliance with cGMP requirements

• Maintain records and keep inventory updated

• Escalate non-conforming products to management, and participate in 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

• Maintain knowledge of SOPs and GMP regulations and guidelines

• Maintain cGMP compliance

• Participate on various projects to improve efficiency or compliance

• Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity
to laboratory management

• Respond promptly to customer needs, solicit customer feedback to improve service, meet commitments.

• Approach others in a tactful manner, react well under pressure, treat others with respect and consideration,
present a professional image in all business matters

• Meet productivity standards, strive to increase productivity without sacrificing quality and safety

• Look for ways to improve and promote quality; demonstrate accuracy and thoroughness

• Observe safety procedures, report potentially unsafe conditions, use equipment and materials properly

• Must be willing and able to work on weekends or extended hours as needed

• 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
KNOWLEDGE, SKILLS & ABILITIES

• General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards is required

• Knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards is preferred

• Knowledge of SAP and/or SAP NEXT preferred

• Good oral and written communication skills

• Good interpersonal skills

• Good documentation skills

• Good math skills: able to add, subtract, multiply, and divide in all units of measure, using whole numbers,
common fractions, and decimals; able to compute rate, ratio, and percentage

• Ability to read, analyze, and interpret instructions, correspondence, policies, procedures

• Ability to write reports, correspondence, and procedures
EDUCATION & EXPERIENCE:

• Minimum AA/AS degree in a biological science or related field is required

• BA/BS degree in biological science or equivalent life science degree is preferred

• Minimum two (2) years of experience in an FDA/ISO or other regulated environment is preferred

• Experience with calendaring, word processing, and spreadsheet software required; experience with
Microsoft 365 (Word, Excel, PowerPoint) preferred
Ideal candidate is a recent college grad or someone with 1-2 years of experience.
worked in a regulated environment
pipetting/testing experience
Detail oriented