Quality Control Technician

Found in: Appcast US C2 - 1 week ago

Rocklin, United States Integrated Resources, Inc ( IRI ) Full time

Must Have:

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.


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.

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