Job Type: Contract
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 firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Senior QC Analyst - Sample Management- Biotech - Dun Laoghaire - 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.
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
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
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)
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
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 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
Excellent Hourly Rate
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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