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Quality Assurance Representative

2 months ago

Fremont, United States GForce Life Sciences Full time

Location: 47361 Bayside Pkwy, Fremont, CA 94538

Job Type: Contract, Hybrid

Job Summary:

We are seeking a detail-oriented and experienced Quality Assurance Representative to join our team in Fremont, CA. In this role, you will conduct routine and non-routine biochemical and chemical analyses of raw materials, in-process items, and finished products. You will be responsible for ensuring all tests are performed according to established procedures, maintaining laboratory equipment, and compiling data for documentation. The ideal candidate will have a strong background in medical devices or pharmaceuticals, experience in QA or regulatory affairs, and a keen eye for compliance and data accuracy.

Key Responsibilities:

  • Perform Analyses: Conduct biochemical and chemical analyses of raw materials, in-process items, and finished products. Ensure all analyses are completed according to established operating procedures.
  • Data Compilation: Compile data for documentation of test procedures, stability program testing, and formulation studies.
  • Equipment Management: Calibrate and maintain laboratory and analytical equipment to ensure optimal performance.
  • Reporting: Participate in preparing investigations, summaries, and reports. Review data for compliance with specifications and report any abnormalities.
  • Procedure Updates: Revise and update standard operating procedures (SOPs) as needed.
  • Special Projects: Undertake special projects related to analytical and instrument problem-solving. Develop new testing and analysis methods and procedures as required.
  • Compliance Management: Manage compliance with internal and external standards and regulations on a day-to-day basis.

Qualifications:

  • Education: Bachelor’s degree in Chemistry, Biochemistry, or a related field. Specialized education or training in analytical chemistry is preferred.
  • Experience: Minimum of 2 years of experience in a similar role, preferably within medical device or pharmaceutical companies. Experience in QA or regulatory affairs is highly preferred.
  • Skills:
  • Strong understanding of biochemical and chemical analysis techniques.
  • Proficiency in the use and maintenance of laboratory equipment.
  • Experience with compliance management and reporting.
  • Ability to work within well-defined procedures and guidelines.

Additional Details:

  • Hiring Manager Notes:
  • Local candidates only.
  • This is a hybrid role.
  • Experience with medical device or pharmaceutical companies is highly preferred.
  • Experience in QA or regulatory affairs is highly preferred.