Job Type: Contract
Job ID: JO-1812-12179
Consultant: Karen McHugh
Are you a QC analyst with Sample and Data management experience within a pharma or biotech environment?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
QC Analyst - 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.
Primary Responsibilities, Accountabilities and Decisions Rights
Execute sample management activities across the site – sample distribution, LIMS logging, shipment receipt
Perform Stability Program related activities such as pulling stability samples, study initiations.
Create/own and approve protocols, sample plans.,SOPs, training manuals.
Perform SAP, LIMS and CIMS 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 and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples
QC Representative for NPI activities and routine Product meetings as required
Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
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:
Liaise with site Planning, Manufacturing and Inspection regarding ADL manufacturing schedule and required QC testing.
Liaise with Stability Product Representatives and Product Quality Leads as required.
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 tasks with efficiency and accuracy.
Report, evaluate, back-up/archive, trend and approve data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents and equipment.
Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
Operate and maintain GMP equipment, including responding and management of GMP alarms.
Introduce new techniques/ Processes to the area, where appropriate.
Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
LIMS data coordination of commercial and import testing lots where applicable
LIMS lot logging for ADL manufactured lots.
Provide technical guidance, may contribute to regulatory filings.
Represent the department/organization on various teams as required. Train others.
Interact with outside resources.
Perform general housekeeping in all sample management areas in line with 5S.
Primary knowledge, skills, competencies and relevant experience
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
Take initiative to identify and drive continuous improvements
Communication skills (verbal and written) at all levels
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
Decision Making skills
Teamwork and Coaching others
Negotiation and Influence skills Investigation skills
Problem solving skills
aApplies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. 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
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project timeframes and priorities based on project objectives and ongoing assignments
iv. 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
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, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Contract rate of €30 - €35 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 firstname.lastname@example.org or call +353-1-7978720
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