Lead QC Biochemist: Method Dev, Validation & Investigations

Actalent; Elwood (KS); Sur place; USD 43 000 - 56 000; Plein temps

Résumé du poste

Actalent is seeking a Biochemist - QC Specialist to lead day-to-day quality control in a fast-paced lab. You will perform release testing, drive method development and validation, and partner with leadership to ensure safety, compliance, and continuous improvement across QC processes.

The role requires deep experience in HPLC and ELISA, strong documentation practices, and leadership capabilities in a regulated environment. This onsite role is based in Elwood, KS with standard shift hours.

Qualifications

• 4+ years of relevant laboratory experience in quality control or analytical environment.
• Bachelor's degree in Biochemistry, Biological Sciences, Pharmaceutical Sciences, or related field; advanced degree with 2+ years experience.

Responsabilités

• Direct daily QC workload and ensure compliance with policies and standards.
• Serve as SME for QC team for instruction, troubleshooting, and data handling.
• Perform routine release testing to support product/material disposition.
• Lead method development, optimization, and validation activities.
• Support technical transfers of analytical methods across labs.
• Lead quality events, deviations, investigations, and change activities with thorough resolutions.
• Review and approve QC documentation for accuracy and compliance.
• Audit inventory management and reagent qualifications; monitor expiries.

Connaissances

HPLC

ELISA

Laboratory operations

Documentation

Leadership/mentoring

Communication

Data integrity

Empower software

Formation

Bachelor's degree in Biochemistry/Biological Sciences/Pharmaceutical Sciences

Advanced degree (MS/PhD) in Biology/Chemistry/Related field

Outils

Empower software

Description du poste

Actalent is seeking a Biochemist - QC Specialist to lead day-to-day quality control in a fast-paced lab. You will perform release testing, drive method development and validation, and partner with leadership to ensure safety, compliance, and continuous improvement across QC processes.

The role requires deep experience in HPLC and ELISA, strong documentation practices, and leadership capabilities in a regulated environment. This onsite role is based in Elwood, KS with standard shift hours.