Quality Control Specialist

Location: Berkeley, CA

Duration: 9 months
Schedule: M-F, 8:00 AM - 5:00 PM

Salary range: $30/hr. - $37/hr. (depending on experience)

Job Description

• Maintains accurate logs, notebooks, and related electronic documentation.
• Performs method feasibility studies, develops analytical methods, and executes laboratory assays for method validation using instruments such as HPLC, UPLC, KF Titrators, Autotitrators, melting point meters, chloride meters, and polarimeters.
• Possesses strong knowledge of chromatography (SEC, ion exchange, normal phase, reverse phase, ion-pair, etc.), electrophoresis (PAGE and/or agarose), spectrophotometry, and wet chemistry techniques used for sample preparation.
• Understands biologics and associated manufacturing processes.
• Troubleshoots analytical methods and instrumentation including HPLC, UPLC, KF Titrators, Autotitrators, melting point meters, chloride meters, and polarimeters.
• Has prior QC laboratory experience and hands-on use of LIMS, SAP, and chromatographic software such as Empower.
• Prepares method development and method validation reports.
• Complies with SOPs, pharmacopoeial requirements, regulations, and safety procedures.
• Follows GDP and GMP standards.
• Manages multiple tasks effectively, works with multiple technical leads, and collaborates with other functions such as manufacturing and research.

Skills Required

• Minimum of 3 years of experience in the relevant technical or logistical specialty needed for the role.
• Ability to work effectively within a regulated laboratory environment following all documentation and compliance expectations.
• Strong understanding of chromatography, electrophoresis, spectrophotometric methods, and wet chemistry procedures.
• Ability to operate and troubleshoot a range of analytical instruments including HPLC, UPLC, KF Titrators, Autotitrators, melting point meters, chloride meters, and polarimeters.
• Experience using LIMS, SAP, and chromatographic data systems such as Empower.
• Ability to follow regulatory guidelines, SOPs, GMP, and GDP.
• Strong multitasking, communication, and cross-functional collaboration skills.

Education/Training/Certifications

• Bachelor’s degree in a scientific or technical field with a minimum of 6 years of experience, or
• Master’s degree with a minimum of 2 years of experience, or
• PhD with no experience required.
• Equivalent education and experience combinations may be considered.

HarveStaff offers a wide variety of competitive compensation and benefits programs.

"We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws."

JOB-10045537
GFCMS

Job Types: Full-time, Contract

Pay: $30.00 - $37.00 per hour

Expected hours: 40 per week

Education:

• Bachelor's (Required)

Experience:

• Packaging: 2 years (Required)
• pharmaceutical or biotechnology: 1 year (Required)
• operating automated equipment: 2 years (Required)
• laboratory environment: 3 years (Required)
• chromatography, electrophoresis, spectrophotometric methods: 3 years (Required)
• Quality Control Specialist: 6 years (Required)

Ability to Commute:

• Berkeley, CA (Required)

Work Location: In person

Salary : $30 - $37