QC Analyst – In-Process Control - Shift

Excitingopening ina newly 5S certified Analytical lab within 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 support 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 is a shift based team, operating a 4 cycle shift pattern (see below).

QC In-Process are a high-performing, team-basedgroup, 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 providing quality testing and delivering results in accordance with GMP standards.

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

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 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