Senior QC Analyst - NPI - Biotech - Dun Laoghaire - Dublin


Location: Ireland

EUR 20 - 30 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19240

Consultant: Karen McHugh






Do you have 5+ years of BioPharma QC experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products?

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 - NPI - Amgen - 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

QC Representative for NPI activities and routine Product meetings 

Assist with activities related to QC projects and/or QC tasks within Site projects 

Manage all sample management activities related to NPI activities throughout the site 

Create/own and approve protocols, sample plans, SOP and documentation related to NPI 

Responsible for their own training and safety compliance. 

Sample shipments and temperature monitoring activities for NPI activities 

LIMS data coordination of non-core ( NPI) activities.  

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

Contributes to team by ensuring the quality of the tasks/services provided by self 

Contributes to the completion of milestones associated with specific projects or activities within team 

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

Specific Job Duties: 

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

Plan and perform analyses with great efficiency and accuracy. 

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

Report, evaluate, back-up/archive, trend and approve analytical data. 

Troubleshoot, solve problems and communicate with stakeholders. 

Initiate and/or implement changes in controlled documents. 

May train others as necessary 

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

Write protocols and perform assay validation and equipment qualification/ verification. 

Introduce new techniques to the lab, including method transfers, reports, validations and protocols. 

May contribute to regulatory filings. 

May conduct lab investigations as necessary. 

Evaluate lab practices for compliance on a continuous basis. 

Approve lab results 

May represent the department/organization on various teams 

May interact with outside resources. 

Create APPX data files and randomisation memo to facilitate data analysis. 

LIMS data coordination of commercial and import testing on site where applicable 

May provide technical guidance. 

May contribute to regulatory filings. 

May represent the department/organization on various teams. May train others. 

May interact with outside resources. 


Requirements

5+ years of bio/pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, 

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

Bachelor’s degree in a Science related field is required. 

Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. 

Deepens technical knowledge through exposure and continuous learning 

Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery 

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

Experience in both Wet Chemistry and HPLC testing techniques 

Extensive experience in laboratory systems such as sample management LIMS, Velquest / Smartlab, Empower software etc.

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 

Project Management and organizational skills, including ability to follow assignments through to completion 

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 time-frames and priorities based on project objectives and ongoing assignments 

Recognizes and escalates problems 

Working knowledge of aseptic 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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