Sr Associate QC-Sample Management-Dublin Contractor

Purpose

• 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.

Responsibilities

• 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.
• 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
• Knowledge:
• 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 discover
• Take initiative to identify and drive continuous 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 other
• 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 the 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 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

Qualifications

• 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.