Quality Control Technician

4 weeks ago


Rocklin, California, United States GTT, LLC Full time
Quality Control Technician
Contract Duration 12 Months
Pay range - $23 to $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, bioburden, slide filling, and IHC; completing required tasks based on QC schedule needs and following 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:
Quality Control Technician performs 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 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
Maintain knowledge of SOPs and GMP regulations and guidelines
Maintain cGMP compliance
Participate in 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
Quality Control Technician responds promptly to customer needs, solicit customer feedback to improve service, and meet commitments.
Approach others in a tactful manner, react well under pressure, treat others with respect and consideration, and present a professional image in all business matters
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
Observe safety procedures, report potentially unsafe conditions, and 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

Required 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 into all units of measure, using whole numbers, common fractions, and decimals; able to compute rate and percentage
Ability to read, analyze, and interpret instructions, correspondence, policies, procedures
Ability to write reports, correspondence, and procedures

Required Education & Experience:
Minimum AA/AS degree in a biological science or related field is required
BA/BS degree in biological science or an 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

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About The Company:


Our client aspires to be the premier research-intensive biopharmaceutical company by using the power of leading-edge science to save and improve lives around the world.

For more than 130 years, they have brought hope to humanity by developing important medicines and vaccines.

Today, they are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Our client fosters a diverse and inclusive global workforce and operates responsibly every day to enable a safe, sustainable, and healthy future for all people and communities.

#gttnonit

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