QC Analyst - Day Position

Location:  Cork, Ireland Category: Quality Employment Category: Fulltime-Temporary

Description

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.

 

Role Summary

 

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.

 

Role Responsibilities

 

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

Behavioral

Accountability Achieving Excellence Communication Courage I Challenge Develop Self & Others Judgement

Reliability Teamwork

 

Technical

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.

 

Signed:

Print Name:Date: 

 

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