Title: Senior QC Associate
Location: Dun Laoghaire
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.
* 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 company 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 company 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.
Qualifications and 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
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
* 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
* 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
* 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.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.