QC Lab Technologist I

QC Lab Technologist I

Kimco has partnered with a leader in procedural surgical solutions. Our client is focused on reinstating patient mobility and the quality of life of patients. Our client is seeking a QC Lab Technologist I. The QC Lab Technologist I is responsible for microbial and chemical testing as it relates to manufacturing and sterilization of medical devices. Practice microbiological techniques, including gram stain, streak plating, fungal identification, dilutions and colony enumeration. Will work with operations and research groups to monitor processes and support continuous quality improvement initiatives.

Pay: $21.00 -$22.00

Location: Irvine, CA

Benefits: Medical, Dental and Vision Insurance, Wellness Programs, Employee Stock Purchase Programs, PTO, Holiday Pay, 401K Plans and Spending Accounts (FSA/DCA/HSA)

The QC Lab Technologist I will be responsible for the following:

• Monitors and performs environmental monitoring of RO/DI water system and clean room.
• Bacterial endotoxin testing of final product and RO/DI water. Task may require validation of methodologies to applicable standards.
• Performs ELISA testing for BMP-2.
• Product and RO/DI bioburden testing where aseptic technique is applicable.
• Assist and support in process validation activities and new product development activities.
• Supports internal/external histology tasks such as; reading slides and preparing data sheets and/or test reports.
• Performs various product validations in relation to on-going studies and/or tests.
• Track, trend and publish monthly Environmental Monitoring reports.
• Performs calibrations and preventive maintenance for applicable equipment.
• Conducts Out Of Specification (OOS). Supports nonconformances (NCMRs) and CAPA investigations.
• Performs chemical analysis such as titration, pH, conductivity, osmolarity, residual calcium (using flame AA), determination of HCl concentration, determination of formaldehyde concentration, shrink test and loss on ignition according to SOP’s.
• Preparation of glassware and understanding of dilutions for applicable tests.
• Other tasks as assigned.

• Possesses knowledge of mechanical equipment, HVAC, refrigeration, fire systems, stand-by emergency power, and preventive maintenance

MINIMUM QUALIFICATIONS

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Bachelor’s degree in Microbiology, Chemistry or other related science

Experience, Skills, Knowledge and/or Abilities:

• 0-2 years’ experience in a similar role, medical device or biologic manufacturing preferred
• Must have the ability to multi-task in a fast-paced environment.
• Must have strong attention to detail and ability in problem solving.
• Must have good verbal and written communication skills; technical writing – have the ability to generate clear and concise documents and procedures

PREFERRED QUALIFICATIONS

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• No Additional Requirement

Additional Experience, Skills, Knowledge and/or Abilities:

• Prefer to have knowledge in one or all of the following: AATB, QSR, cGMP, ISO 13485, ISO 17025, ISO 11137, ISO 11737, ISO 14644 and USP.

About Kimco Staffing Services
With 30 years of award-winning service in California, Kimco offers flexible employment options including temporary, contract and direct hire through our specialized practices: office professionals, accounting operations, technical support, and industrial staffing. Last year we filled more than 22,000 jobs.