- 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).
- 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
- 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
- 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
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Quality Control Technician - Rocklin, United States - Randstad Life Sciences
Description
Job Description
Job Description1 Year Contract
Rocklin, CA
PR: $20-25/hr
PRIMARY OBJECTIVE OF POSITION:
Essential Functions:
KNOWLEDGE, SKILLS & ABILITIES
EDUCATION & EXPERIENCE:
