QC Analyst (TEMPORARY)

at  Biomarin

SUMMARY DESCRIPTION

We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Reporting to the QC Team Leader, 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. Ensuring our products are safe for patient use and fit for purpose.
The team is divided into 3 sub-teams QC Analytical; QC Microbiology and QC In-Process. The role could potentially lie within any of these sub-teams depending on experience and requirement. Shift work may be required.

SKILLS/ KNOWLEDGE/ BEHAVIOURS

The role potentially will cover both Analytical and Microbiological testing including but not limited to the following:
Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs
Anaytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis
Testing of finished product, raw materials, packaging and stability
Perform primary review of QC raw data and trend results
Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
Develop, optimize, validate and troubleshoot analytical test methods
Draft 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
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

B.S. in a scientific discipline with 3+ years of relevant laboratory experience.

EXPERIENCE

• Ability to work independently and meeting established timelines.
• Comfort with coordinating the activities with other staff members.
• Comfort with working in a team environment
• Knowledge of cGMPs.

Days role Monday – Friday
23 month temporary contract