Senior QC Analyst - Sample Management- Biotech - Dun Laoghaire - Dublin


Location: Ireland

EUR 25 - 35 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19235

Consultant: Karen McHugh






Do you have 3+ years of biopharmaceutical QC experience?

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.


Senior QC Analyst - Sample Management- Biotech - Dun Laoghaire - Dublin


Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 


Job Description

Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance. 

Contributes to the team by ensuring the quality of all tasks/services provided by self. Contributes to the completion of milestones associated with specific projects or activities within team. 

This role will support QC, NPI and manufacturing operations, as such some extended hours, out of hours and weekend work flexibility may be necessary as required. 

Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters. 

Perform routine sample management tasks as per procedures. 

With a high degree of technical flexibility, work across diverse areas within QC 

Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks. 

Troubleshoot, solve problems and communicate with stakeholders. 

Initiate and/or implement changes in controlled documents. 

Participate in audits, initiatives, and projects that may be departmental or organizational in scope. 

Introduce new techniques/ Processes to the area, where appropriate. 

Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis. 

May provide technical guidance. May contribute to regulatory filings. 

May represent the department/organization on various teams. 

May interact with outside resources. 

Perform general housekeeping in all sample management areas. 

Support all NPI activities with QC 


Requirements

3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical industry, 

Bachelor’s degree in a Science related field is required

Would be advantageous if the candidate has a minimum of 2 years of specific sample management/ stability Programme management experience. 

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. 

Primary Responsibilities, Accountabilities and Decisions Rights 

Sample management activities across the site 

Create/own and approve protocols, sample plans, SOP and documentation 

Responsible for SAP and LIMS functions/ transactions within the sample management remit 

Out of hours responder for sample management equipment (fridges /freezers / incubators) 

Responsible for their own training and safety compliance. 

Sample shipments and temperature monitoring activities. 

LIMS data coordination of commercial and import batches. 

Management of the Inventory of Reference Standards and assay controls, training and verification samples 

QC Representative for NPI activities and routine Product meetings

Skills: 

Take initiative to identify and drive improvements 

Communication skills (verbal and written) at all levels 

Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) 

Presentation skills 

Escalate issues professionally and on a timely basis 

Decision Making skills 

Teamwork and Coaching others 

Negotiation and Influence skills 

Investigation skills 

Problem solving skills applies research, information gathering, analytical, and interpretation skills to problems of diverse scope 

Ensures compliance within regulatory environment 

Develops solutions to technical problems of moderate complexity 

Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues 

Interprets generally defined practices and methods 

Able to use statistical analysis tools to perform data trending and evaluation 

Competencies: 

Demonstrated ability to work independently and deliver right first-time results 

Works under minimal direction Work is guided by objectives of the department or assignment 

Follows procedures 

Refers to technical standards, principles, theories and precedents as needed 

May set project timeframes and priorities based on project objectives and ongoing assignments 

Recognizes and escalates problems 

Working knowledge of compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues 

Auditing documentation and operation process 

Demonstrated ability to interact with regulatory agencies 


Package

Excellent Hourly Rate

Minimum 12 month contract


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720

TAGLab


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