Quality Control Specialist I

About the role

Perform a broad variety of basic (particle, stability, shelf-life, conductivity, pH) and advanced testing of raw materials and finished goods. Conduct microbiological tests, including environmental and sample monitoring. Read and interpret microbiological cultures and other related tests. Perform first article testing, troubleshooting, root cause analysis and feasibility/capability studies. Identify materials that are out of spec or tolerance, issue appropriate notifications and maintain batch records.

Responsibilities

• Perform basic pH, conductivity, particle, finished goods, shelf life, stability and pre-purchase/pre-qualification testing using pH meters, conductivity meters, electrophoresis, western blotting and ELISA techniques.
• Perform QC functional assays.
• Create batch records.
• Requisition materials.
• Generate COFAs (Certificates of Analysis).
• Pipette validation.
• Validate QC protocols and testing methodologies.

Requirements

Education: Bachelor's degree or equivalent in a life science (Chemistry, Biology) or related field. Advanced degree preferred.

Work Experience: 0-2 years in a general laboratory environment performing analyses in the areas of chemistry, biochemistry, or associated areas of life sciences, or equivalent combination of education and experience.

Understands and can apply GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices).

Strong computer skills.

Experience with ERP systems a plus, SAP preferred.

Qualifications

None specified.

Skills

Basic laboratory testing skills.

Advanced laboratory testing skills.

Microbiological testing skills.

Data analysis skills.

Batch record creation skills.

Material requisitioning skills.

Certificate of Analysis generation skills.

Pipette validation skills.

QC protocol and testing methodology validation skills.

Benefits

Includes competitive medical plans, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

Pay

The estimated base salary range for this position is $70,310 to $85,300 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Schedule

This position must be based in Hercules, CA and requires the employee to be located within commuting distance of the office.