QC Analyst - Day Position
BiOMA R I N.
Job Title: Quality Control Analyst Employee Type: Permanent Location: Ireland - Cork
BioMarin in Ireland
In Ireland, BioMarin operates a Biopharma Manufacturing Site in Shanbally, Co. Cork, and a Global Commercial Operations Hub in Dublin.
What makes working here unique? At BioMarin, we feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives. As BioMarin employees, we're here because we want to be here. We enjoy our work -and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward.
We are a high-performing, team based organisation, 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 organisational 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.
The role potentially will cover Microbiology testing including but not limited to the following:
• Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & Bis
• Supporting activities in Drug Product – including media fills
• Supporting method development and validation
• 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 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 Required
• B.S. in a scientific discipline with 3+ years of relevant laboratory experience. Experience Required
• 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. Supervisor Responsi bil ity
• No direct reports Competencies Required
Accountability Achieving Excellence Communication Courage I Challenge Develop Self & Others Judgement
Technical Knowledge & Expertise Attention to Detail
Compliance Documentation IT Applications
Workload & Time Management
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.