Quality Control Chemist I

Responsibilities

• Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays.
• Work with internal and external resources to maintain the lab in an optimal state.
• Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance, and drug product release.
• Supply information to support generation of Certificates of Analysis (CoAs) for product release.
• Maintain laboratory instruments for calibration and routine maintenance.
• Author or revise SOPs, qualification/validation protocols, and reports.
• Assist with lab investigations regarding out-of-specification (OOS) results.
• Participate in determination of root cause for deviations related to analytical procedures.
• Provide updates at daily and weekly meetings.
• Monitor GMP systems to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Perform other duties as required.

Requirements

• Bachelor’s Degree OR AA Degree and 2+ years of experience in biotechnology or a related field and Quality Control experience OR High School Diploma and 3+ years of experience in biotechnology or a related field and Quality Control experience.

Preferred Qualifications

• Strong knowledge of GMP, SOPs, and quality control processes.
• Experience identifying, writing, evaluating, and closing OOSs and investigations.
• Proficient in MS Word, Excel, PowerPoint, and other applications.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Well-versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays, and other applicable methods for testing biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
• Preferred: Experience in the biotech and/or pharmaceutical industry.

Pay

$25–$30/hour.