QC Analyst – Analytical

Exciting opening in a newly 5S certified Analytical lab within QC Release at Biomarin.  This role will be focused on the ongoing support of Biomarin’s Enzyme Replacement Therapy products for release and stability.  It also provides an excellent opportunity to be involved in Process Performance Qualifications (PPQs) as part of the rapidly expanding Shanbally site including the new fill finish facility and packaging operations. 

QC Release are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. QC Release 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, the primary role of the QC Analyst is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards.

The role primarily covers testing of HPLC/UPLC in addition to plate-based assays as required by the team.  The dynamic nature of the team also provides the opportunity for bioassay and/or viral gene therapy testing. 

Other 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 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

 

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 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 organisation

Education:

MSc in a scientific discipline with 1+ years of relevant laboratory experience.