Senior Quality Assurance Laboratory Technician

2 weeks ago

Torrance, California, United States Sakura Finetek USA Full time
Job Overview

Position Summary:

The Senior Quality Assurance Laboratory Technician plays a crucial role in maintaining high-quality standards by executing approved testing and inspection protocols. This position involves analyzing product failures, conducting thorough investigations, and making informed decisions to identify root causes while recommending and implementing suitable corrective measures. The technician will engage in QA/testing activities related to the development and deployment of specifications, specialized controls, tests, inspections, validations, and verifications essential for ensuring the quality of products.

Key Responsibilities:

Quality Assurance Support:

  • Actively contribute to the enhancement and maintenance of the company's Quality Management System, taking ownership of specific job processes and collaborating with related teams.

Supplier Management:

  • Assist in evaluating, selecting, and monitoring supplier quality to ensure compliance with product specifications.

Technical Operations:

  • Represent the Quality Control team in ongoing projects during product launches and special initiatives.
  • Conduct analysis of raw materials, in-process materials, and finished products using various techniques including IHC, ISH, ELISA, and molecular/biochemical methods.
  • Document and interpret test results in accordance with established quality control standards.
  • Oversee documentation updates within the Quality Control department.
  • Inspect in-process and final products to ensure adherence to quality standards.
  • Monitor quality control equipment to ensure proper calibration and functionality.
  • Maintain laboratory instruments and facilities in optimal working condition.
  • Execute validation protocols for processes and testing equipment.
  • Communicate any issues that may impact product quality to management.
  • Ensure cleanliness of laboratory areas and biosafety cabinets.
  • Manage the retention area and samples for Quality Control.
  • Coordinate with Production Management to schedule activities that align with customer orders and inventory levels.
  • Conduct investigations into discrepancies in materials and processes, compiling data and analyzing issues related to root causes while initiating corrective actions for deficiencies.

Data Management and Reporting:

  • Perform data analysis and provide feedback through charts, graphs, and reports to assess the effectiveness of the Quality System.

Additional Responsibilities:

  • Support the review and analysis of specifications, technical manuals, and related documentation.
  • Assist in drafting and establishing Operating Procedures (OP).
  • Provide support in the evaluation and validation of equipment used by Quality Control.
  • Participate in audits and verifications of compliance processes prior to product acceptance.
  • Assist in field failure analysis and corrective actions, liaising with Product Support, R&D, and Technical Service Departments.
  • Contribute to training programs to ensure personnel impacting product quality are adequately qualified.
  • Document and control nonconforming products and maintain lab supplies to meet production needs.

Qualifications:

Education:

  • Bachelor's degree in Biological Sciences, Biochemistry, or a related field, with additional coursework in quality and quantitative methods considered a plus.

Experience:

  • A minimum of five to six years of relevant experience or an equivalent combination of education and experience.
  • Prior experience in GMP/GLP environments is preferred.
  • Proven ability to work independently and troubleshoot effectively.
  • Strong organizational skills to prioritize tasks and meet deadlines.
  • Ability to adapt to changing environments and work under pressure.
  • Excellent communication skills to address inquiries from customers and regulatory bodies.
  • Solid mathematical skills, including the application of advanced concepts.
  • Knowledge of biochemical processes and Quality Control methods.
  • Ability to work collaboratively with diverse personalities.

Physical Requirements:

  • Ability to lift up to 50 lbs. with assistance.
  • Frequent work in a laboratory setting.
  • Ability to travel as required.
  • Proficient in reading and analyzing information both in print and on screens.
  • Capability to manage multiple tasks and deadlines effectively.

Sakura Finetek USA, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable law.

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