QC Lab Lead - Method Development, Validation & Transfers

Actalent; Elwood (KS); In loco; USD 43.000 - 56.000; Tempo pieno

Descrizione del lavoro

Actalent is seeking a Biochemist - QC Specialist for a contract role in Elwood, KS. You will lead day-to-day QC activities, drive method development and validation, and support technical transfers to ensure compliant analytical practices.

You will act as SME for key equipment, lead quality events and investigations, and partner with leadership to optimize processes while upholding safety and quality culture.

Competenze

• 4+ years of quality control or related analytical lab experience.
• Bachelor's or higher in a relevant science field.
• Hands-on experience with HPLC in an analytical lab.
• Hands-on experience with ELISA techniques.
• Direct experience in analytical lab operations, documentation, and compliance.
• Experience in leadership or training roles in a lab environment.

Mansioni

• Direct daily QC workload and ensure adherence to policies and procedures.
• Provide technical instruction and troubleshooting for the QC team.
• Perform routine release testing to support product and material disposition.
• Lead method development, optimization, and validation activities.
• Coordinate method transfers and ensure proper documentation across labs.
• Lead deviations, investigations, and change control with timely resolutions.
• Review QC documentation for accuracy and compliance.
• Audit inventory management and reagent qualification processes.
• Prepare laboratories for inspections and audits and support audits.

Conoscenze

Laboratory experience

HPLC

ELISA

Analytical lab operations

Leadership/mentoring

Verbal communication

Written communication

Interpersonal skills

Attention to detail

Change leadership

Empower software

Formazione

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

Advanced degree (Masters/PhD) in Biology / Chemistry or related with experience

Strumenti

Empower software

Descrizione del lavoro

Actalent is seeking a Biochemist - QC Specialist for a contract role in Elwood, KS. You will lead day-to-day QC activities, drive method development and validation, and support technical transfers to ensure compliant analytical practices.

You will act as SME for key equipment, lead quality events and investigations, and partner with leadership to optimize processes while upholding safety and quality culture.