Job Description
QC Analyst – In-Process Control - ShiftExciting 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:7-7Week/DayMonTueWedThuFriSatSun1DDDDD2DD3NNNNN4NN5DDDDD6DD7NNNNN8NN #J-18808-Ljbffr