Quality Control Investigations Specialist (Hybrid)

BioSpace; Novato (CA); Hybrid; USD 110,000 - 140,000; Full time

Job summary

BioMarin is seeking an Associate II, QC Technical to own laboratory investigation processes within the QMS. The role collaborates with QC supervisors, leads, and analysts to plan and advance investigations, identify root causes, and ensure timely closure of records to support critical business objectives.

Strong data gathering and cross-functional collaboration are essential. The position requires 6+ years in a cGxP lab, RCA experience, and solid knowledge of chemistry and analytical methods.

Qualifications

• 6+ years in a cGxP laboratory or related setting.
• Proficiency with Root Cause Analysis (RCA) and Operational Excellence mechanisms.
• Knowledge of core chemistry principles and analytical methodologies (purification, pH, bioburden, endotoxin, spectrophotometry, chromatography, ELISA, PCR, PAGE/CE).
• High accuracy and attention to detail.
• Strong written and verbal communication skills.
• Strong time management, critical thinking, problem solving, and leadership.
• Proficiency with QMS record and control document management software such as Veeva; MS Office proficiency.

Responsibilities

• Facilitate and complete QC laboratory investigations (LIRs) for OOS, OOT, OOE, and test failures, prioritizing by impact and urgency.
• Lead deviation investigations and adverse trend reviews in QC environments.
• Document investigation findings and prepare trend or technical reports.
• Gather data, observe processes, and conduct personnel interviews.
• Coordinate cross-functional root cause analysis and define CAPAs.

Skills

RCA

cGxP knowledge

Quality documentation

Analytical skills

Education

B.S./B.A. in science-related field

Tools

Veeva

MS Office

Job description

BioMarin is seeking an Associate II, QC Technical to own laboratory investigation processes within the QMS. The role collaborates with QC supervisors, leads, and analysts to plan and advance investigations, identify root causes, and ensure timely closure of records to support critical business objectives.

Strong data gathering and cross-functional collaboration are essential. The position requires 6+ years in a cGxP lab, RCA experience, and solid knowledge of chemistry and analytical methods.