Job Type: Contract
Job ID: JO-1901-12382
Consultant: Karen McHugh
Are you a QC analyst with NPI experience within a pharma or biotech environment?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Senior QC Analyst - NPI - Sample Management - Amgen - Dublin
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.
QC Representative for NPI activites and routine Product meetings
Assist with activities related to QC projects and/or QC tasks within Site projects
Plan and Perform non-core testing related to NPI activites
Manage all sample management activities related to NPI activites 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 activites
LIMS data coordination of non-core ( NPI) activites.
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.
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.
Bachelor’s degree in a Science related field is required.
5+ years of biopharmaceutical 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.
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
Communication skills (verbal and written) at all levels
Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Escalate issues professionally and on a timely basis
Decision Making skills
Teamwork and Coaching others
Negotiation and Influence 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
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
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 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
Contract rate of €25 - €30 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail email@example.com or call +353-1-7978720
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