QC Analyst – In-Process Control - Shift Exciting opening in a newly 5S certified Analytical lab within the QC In-Process team at BioMarin. This is a very diverse role which encompasses all the in-process testing (both analytical and microbial) for the Drug substance and Drug product facilities on site. In addition, the in-process team supports testing for all incoming raw materials and testing of the incoming packaging materials for the pack lines.
Due to the fast-paced nature of the in-process group, the team operates on a shift-based schedule, following a 4-cycle shift pattern.
QC In-Process is a high-performing, team-based group, where colleagues are flexible, multi-skilled, and empowered to make decisions. QC In-Process operates to an extremely high standard of quality and compliance.
A high level of initiative, energy, and motivation are key role requirements, as well as organizational skills.
Reporting to the QC Team Lead/Manager, the primary role of the QC Analyst is to provide support to internal customers by delivering quality testing results in accordance with GMP standards.
Responsibilities include: Perform primary review of QC raw data and trend results.Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies.Draft/Update QC SOPs.Act as a technical resource (SME) and train other analysts in areas of expertise.Evaluate results against defined acceptance criteria.Conduct and document laboratory investigations to completion.Maintain the laboratory in an inspection-ready state.Interact directly with regulatory agency inspectors during audits.Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.Other duties as assigned.
Desirable Skills: Excellent communication skills both written and verbal.Customer focus; takes personal responsibility for speed, quality, and accuracy of delivery.Self-motivated and ability to work under pressure.Team Leadership – active participation in team development and continuous improvement including standard work and 5S.Successful track record in achieving goals as part of a team within a growing, dynamic environment.Demonstrated adaptability and flexibility to support a growing organization.Education: BSc in a scientific/engineering discipline with 5+ years (MSc with 3+ years) of relevant (cGMP) laboratory experience.
4 Cycle Shift Pattern: 7-7
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