QC Specialist Sample Management
This job specification outlines the general responsibilities associated with the role of QC Specialist Sample Management at Amgen Dun Laoghaire. This role will be responsible for owning, coordinating, facilitating, and undertaking activities pertaining to Sample Management within QC, without direct supervision and as a backup to QC Sample Management Manager. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for Sample Management duties, including release of commercial and global release testing. The role also represents the QC unit by liaising with internal and external stake holders. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the role.
Primary Responsibilities, Accountabilities and Decisions Rights:
- LIMS lot authorisation of commercial and Global IDP release testing;
- Oversight of ADL Stability programme;
- Manage sample management activities across the site;
- Create/own and approve protocols, sample plans, SOPs and documentation;
- Responsible for SAP and LIMS functions/transactions within the sample management remit;
- Management and maintenance of Reference standards and reserves for the site including Reference Standards and assay controls, training and verification samples;
- Out of hours responder for sample management equipment (fridges/freezers/incubators);
- Sample shipments and temperature monitoring activities;
- QC Representative for Sample Management at Amgen network meetings and sample management forum.
Under minimal direction, functions as the technical specialist for Sample Management area and is 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
- LIMS lot authorisation of commercial and Global IDP elease testing on site;
- Oversight of Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme requirements;
- Perform routine sample management tasks as per procedures;
- With a high degree of technical flexibility, work across diverse areas within QC;
- Plan and perform routine tasks with efficiency and accuracy. Troubleshoot, solve problems and communicate with stakeholders;
- Participate in audits and continuous improvement projects that may be departmental or organizational in scope;
- Review and approve validation and equipment qualification/verifications. Operate and maintain specialised equipment;
- Introduce new techniques/Processes to the area, where appropriate. Seek out opportunity to improve Sample Management processes;
- Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis;
- May provide technical guidance. Provide coaching and support to the Sample Management team. May contribute to regulatory filings;
- May represent the department/organization on various teams. May train others;
- May interact with outside resources;
- Perform general housekeeping in all sample management areas;
- Act as point of contact across Amgen network for Sample Management forum, Stability network, ABR for Global IDP release, QC testing for product launches in US, Europe etc.
Primary knowledge, skills, competencies and relevant experience
- Broad technical knowledge within Sample Management area and expanding knowledge of related disciplinary areasRecognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization;
- Enhances own knowledge through understanding business trends and objectives;
- Knowledge of industry and business principlesUnderstands the core business process and purpose of the functional area in Amgen’s commercialization process;
- Developing own project management techniques.
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information;
- Creates new procedures and processes to drive desired results;
- Handles diverse scope of issues that require evaluation of a variety of factors including current business trends.
- Works under minimal direction;
- Work is guided by operational and project objectivesManages multiple assignments and processes;
- Independently determines approach to project;
- May be responsible for specific programs and/or projects;
- Independently develops solutions that are thorough, practical, and consistent with functional objectives.
- Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean;
- Provides training and guidance to others;
- Extends capabilities by working closely with senior staff/experts within and outside the internal organization.
- Take initiative to identify and drive improvements;
- Communication skills (verbal and written) at all levelsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls);
- Presentation skills;
- Escalate issues professionally and in a timely basis and know when to escalate;
- Decision Making skills – will be require to make decisions independently;
- Teamwork and Coaching others;
- Negotiation and Influence skills, Planning and organisation skills;
- Investigation skills;
- Demonstrated ability to interact with regulatory agencies.
- Bachelor’s degree in a Science related field is required;
- 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with of 2–3 years of specific sample management/stability programme management experience is desirable;
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products;
- Strong working knowledge of LIMS and CIMS is preferred. Previous SAP experience while not required, would be an advantage.