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Description

The Quality Control Analyst II supports quality control activities across development through commercial programs by performing routine and non-routine analytical testing in a regulated laboratory environment. This role contributes to data integrity, method execution, investigation support, and laboratory operations while ensuring compliance with applicable regulatory standards and project timelines. The Analyst II may also support method transfers, method qualification/validation, and continuous improvement initiatives.

Key Responsibilities

• Perform routine and non-routine analytical assays of increasing complexity in support of raw materials, in-process samples, product release, and stability studies, following approved SOPs.
• Maintain accurate and current training records and adhere to testing schedules to ensure timely completion of assigned work.
• Support day-to-day laboratory operations, including equipment maintenance, reagent preparation, sample preparation, and inventory management.
• Ensure timely and accurate submission of analytical data; may serve as a data reviewer to support efficient data availability.
• Execute role-specific operational activities such as raw material sampling and testing, environmental monitoring, and product testing.
• Assist with method transfers, method qualification/validation, verification, and implementation activities as assigned.
• Contribute to the revision and maintenance of controlled documents, including SOPs, work instructions, and test methods.
• Adhere to internal standards, policies, and procedures, as well as regulatory and industry requirements (e.g., GMP, GLP, ICH).
• Collaborate with QC and cross-functional teams to support seamless quality control operations.
• Participate in inspection readiness activities and support internal and external audits and inspections.
• Assist with data verification activities for regulatory submissions, as needed.
• Support continuous improvement initiatives to enhance QC processes, laboratory efficiency, and effectiveness.
• Collaborate with Manufacturing, Materials Management, and Quality Assurance to ensure alignment with operational and business objectives.
• Pursue ongoing training and development to strengthen technical expertise and regulatory knowledge.

Requirements

Qualifications

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field; Associate degree, Biotech Certificate, or equivalent experience may be considered.
• 4–8 years of experience in the pharmaceutical or biotechnology industry within a regulated Quality Control or laboratory environment.
• Experience performing analytical testing in compliance with GMP/GLP requirements.
• Data analysis experience preferred.
• Ability to work under direction with strong attention to detail in a dynamic environment with shifting priorities.
• Strong communication and teamwork skills with the ability to collaborate effectively across functions.
• Familiarity with LIMS and proficiency in Microsoft Excel, Word, and PowerPoint preferred.

Tools & Systems

• UPHPLC
• HPLC
• Excel
• LIMS

Benefits

• 10 month contract
• Administrative shift