Quality Control Analytical Chemist

Quality Control Analytical Chemist

Johnson Service Group, has an immediate opportunity for a Senior Quality Control Analytical Chemist for a biotech manufacturing company in Carlsbad. Direct hire | Onsite | $130K - $140K depending on qualifications. Summary: We are seeking a dedicated Senior Quality Control Analytical Chemist to support laboratory operations by conducting in-process, finished product, and stability testing. This role also includes testing environmental monitoring and raw material samples. The QC Analytical Chemist ensures compliance with QC policies, company standards, and cGMP guidelines while maintaining the highest level of data integrity.

Key Responsibilities:

• Manage and track incoming samples using a Laboratory Information Management System (LIMS) or other tracking methods.
• Perform chemical analyses on production, stability, validation, and qualification samples using both compendial and non-compendial methods.
• Operate advanced analytical instruments such as HPLC/UHPLC, SoloVPE, Maurice (cIEF and SDS-PAGE), FTIR, and UV/Vis Spectrophotometers.
• Author and review technical documents, including method qualification, verification, validation, and suitability reports.
• Ensure adherence to data integrity principles in sample handling and analysis.
• Manage deviation investigations, OOS (Out-of-Specification) results, and implement CAPAs and change controls in compliance with GMP requirements.
• Develop, review, and revise QC-related Standard Operating Procedures (SOPs).
• Serve as a QC liaison to product sponsors, addressing QC-related inquiries.
• Participate in the review and approval of Manufacturing Batch Records for QC-related activities.
• Support and execute analytical method transfers and product-specific test methods.
• Train junior staff in laboratory procedures and safety protocols.
• Perform installation and operational qualification of analytical instruments as needed.
• Ensure full compliance with SOPs and safety regulations in all daily QC Chemistry lab operations.

Qualifications & Requirements:

• Bachelor's degree (B.A. or B.S.) in a Life Science discipline.
• Minimum of 7 years of Quality Control experience in a GMP-compliant environment within the medical device or biopharmaceutical industries.
• Expertise in analytical methodologies, including: buffer characterization (pH, conductivity, osmolality), concentration analysis (UV/Vis and/or fluorescence), chromatography (HPLC, electrophoresis).
• Strong documentation skills with an emphasis on accuracy and detail.
• Ability to work independently with minimal supervision, demonstrating a strong work ethic and accountability.
• Experience collaborating with cross-functional teams, including Manufacturing, Tech Transfer, Quality Assurance, and Senior Management.
• Excellent problem-solving, communication, and interpersonal skills.
• Ability to thrive in a fast-paced, dynamic environment while ensuring regulatory compliance.

Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.