Senior QC Analyst — Biopharma Analytical Specialist

Lancesoft; Fremont (CA); In loco; USD 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Lancesoft seeks a SR QC Associate to join the QA/QC group in a multi-product biopharma facility in the United States. The role covers QC functional areas including HPLC and related testing, with responsibilities that span method development, documentation and compliance under cGMP standards.

Responsibilities include coordinating routine analytical testing, training staff, and ensuring data integrity. Candidates should have strong analytical chemistry knowledge and the ability to work with

Competenze

• Experience with analytical methodologies in biopharmaceutical manufacturing.
• Strong written and verbal communication skills.
• Reading and interpreting SOPs and methods in cGMP/GDP settings.

Mansioni

• Execute and coordinate analytical testing of bulk drug substances and drug products.
• Coordinate raw material sampling and testing and sampling in clean rooms.
• Author test methods, specs, plans, reports, forms and SOPs.
• Train other associates on methods and compliance.

Conoscenze

Analytical methodologies

Written communication

Verbal communication

Quality systems

Formazione

Bachelor's/Associate/High School with cGMP experience

Strumenti

cGMP systems

Descrizione del lavoro

Lancesoft seeks a SR QC Associate to join the QA/QC group in a multi-product biopharma facility in the United States. The role covers QC functional areas including HPLC and related testing, with responsibilities that span method development, documentation and compliance under cGMP standards.

Responsibilities include coordinating routine analytical testing, training staff, and ensuring data integrity. Candidates should have strong analytical chemistry knowledge and the ability to work with