Quality Control Laboratory Technician

Position Summary

The QC Analyst II will perform analytical testing and data review in support of late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. A strong foundation in protein chemistry is essential to effectively perform and troubleshoot a range of techniques, including HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based bioassays. This role requires proven collaboration skills to drive the timely resolution of projects, investigations, and process improvements in partnership with cross-functional teams.

Essential Duties & Responsibilities

Perform analytical testing to support in-process, release, raw material, and stability programs.

Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines.

Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans.

Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports.

Conduct root cause analyses as part of laboratory investigations and assist in closing quality events.

Support regulatory and internal audits as needed.

Perform additional duties as assigned.

Adhere to all company policies and procedures.

Position Requirements and Qualifications

Education:

Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field with a minimum of 3+ years of experience in a pharmaceutical/biotech QC laboratory,

Experience:

Hands-on experience working in a cGMP-compliant laboratory.

Strong expertise in both small molecule and protein chemistry, including troubleshooting analytical data.

Proficient in drafting, revising, and adhering to SOPs, policies, and analytical methods.

Technical Skills:

Proficient in analytical techniques such as HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays.

Experience supporting regulatory inspections (e.g., PAI).

Familiarity with preparing regulatory submissions and data packages for interactions with regulatory agencies (e.g., FDA).

Work Environment & Physical Demands

Time will be split between office duties (reviewing and authoring documents) and hands-on laboratory work.

Extended hours or weekend shifts may be required depending on workload and project deadlines.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!