You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories. The role requires engagement in continuous improvement initiatives to drive efficiency and effectiveness of our client company's Quality Systems.

Key Responsibilities

• Conduct analytical testing to support product in-process, release, and stability programs.
• Possess strong knowledge of cGMP, Quality Systems, and ICH/regulatory guidance.
• Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative action plans.
• Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
• Train other analysts to perform laboratory procedures and assays.
• Participate in internal assessments and audits as required.
• Ensure compliance with all company policies and standards.

Qualifications

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory, or
• Master’s degree in the aforementioned fields with 3 years of experience, or
• PhD in the aforementioned fields with a minimum of 2 years of experience.

Experience

• Previous experience in a cGMP laboratory.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods.

Skills

• Proficiency in techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
• Experience supporting regulatory inspections (e.g., PAI).
• Familiarity with preparing regulatory dossiers and data packages for interactions with regulatory agencies.

Additional Requirements

• Must be able to work extended hours or weekends as requested.
• Ability to lift at least 25 lbs.
• Capable of working under pressure and meeting deadlines in a high-paced environment.

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.