Quality Control Technician

1 Year Contract

Rocklin, CA

PR: $20-25/hr

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