Immediate opportunity for two (2) Quality Control (QC) Analysts to perform testing of biological and chemical evaluation of final product, intermediate products, raw materials, and production facilities with a multinational pharmaceutical company located in Berkeley, CA.
Schedule/Shift: 1st shift, Mon.-Fri.
Position Type: 1 year contract role; potential to be permanent role. However, it depends on multiple factors such as employee’s performance and business needs.
Position Summary: This dynamic role offers a balanced blend of hands-on laboratory work, data analysis, and lab maintenance responsibilities, all critical to ensuring the highest quality standards in biopharmaceutical manufacturing. As a QC Chemistry Associate, you will conduct diverse analytical testing, including HPLC, uniformity assessments, and particle counting, to support the release and stability testing of Factor VIII products. Your expertise will drive process improvements to prevent defects, optimize costs, and maintain consistency across product lines.
Essential Duties and Responsibilities:
- Performing QC assays including HPLC analysis, uniformity testing, particle counting, etc.
- Performing and documenting chemistry tests with precision and adherence to SOPs.
- Analyzing and reviewing data to ensure compliance with regulatory and quality standards.
- Proactively maintaining laboratory inspection readiness by conducting routine maintenance and calibration of equipment.
- Writing and establishing specifications
- Assisting in the validation of QC assays
- Writing Standard Operating Procedures (SOPs)
- Collaborating with cross-functional teams to troubleshoot, streamline processes, and uphold company's commitment to excellence.
Qualifications:
- Bachelor's Degree (BS) in Chemistry, Biochemistry or related field.
- Pharmaceutical industry or academic HPLC experience
- Chemistry lab experience
- Team work mindset
- Flexibility, Detail oriented
- Knowledge of commonly-used concepts, practices, and procedures within a particular field.
- Relies on instructions and pre-established guidelines to perform the functions of the job.
- Works under immediate supervision. Typically reports to a supervisor or manager.