Senior Quality Assurance Specialist

2 weeks ago


Fremont, California, United States GForce Life Sciences Full time

Key Responsibilities:

  • Execute routine and non-routine biochemical and chemical analysis of raw materials, in-process items, and finished products, adhering to established operating procedures, ensuring consistency and accuracy in testing practices.
  • Compile and document test data, participate in stability program testing, and contribute to formulation studies, maintaining high-quality standards.
  • Calibrate, maintain, and troubleshoot lab and analytical equipment as needed, ensuring optimal performance and reliability.
  • Review testing data for compliance with specifications, identify abnormalities, and assist in investigations, promoting a culture of quality and accountability.
  • Revise and update standard operating procedures (SOPs) to maintain consistency and accuracy in testing practices, ensuring compliance with regulatory guidelines.
  • Assist in developing testing methods and procedures in line with regulatory guidelines, staying up-to-date with industry developments.
  • Manage compliance tasks as part of QA or regulatory affairs, particularly with medical device or pharmaceutical product standards, ensuring GForce Life Sciences meets regulatory requirements.

Requirements:

  • Minimum of 2 years of experience in quality control, preferably within the medical device or pharmaceutical industry, with a strong track record of quality assurance.
  • Bachelor's degree in a relevant field or equivalent specialized education and training, with a focus on quality control and assurance.
  • Familiarity with QA and regulatory affairs, with the ability to manage compliance effectively, ensuring adherence to regulatory standards.
  • Proficient in lab equipment calibration and maintenance; experience in analytical problem-solving, with a strong attention to detail.
  • Knowledge of defined procedures and testing guidelines within the quality control or regulatory framework, with a focus on consistency and accuracy.
  • Excellent attention to detail and documentation skills, with the ability to communicate complex ideas effectively.


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