- QC Representative for site / laboratory upgrade projects
- Plan and manage QC related activities from site projects.
- QC Representative for NPI activities and routine Product meetings
- Plan and Perform non-core testing related to NPI activities
- Manage all sample management activities related to NPI activities throughout the site Sample shipments and temperature monitoring activities for NPI activities
- Create/own and approve protocols, sample plans, SOP and documentation related to NPI
- Responsible for their own training and safety compliance.
- Assist with resource management, QC Project Management and other work streams as required by the lab management.
- Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports.
- Under minimal direction, functions as the specialist for non- core project team (NPI) functions and is responsible for one or more of the following activities in QC including analytical testing, characterization, sample, data management, equipment qualification and
- 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.
- With a high degree of technical flexibility, work across diverse areas within QC
- Plan and perform analyses with great efficiency and accuracy.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- May train others as necessary
- Participate in audits, initiatives and projects that may be departmental or organizational in scope.
- Write protocols and perform assay validation and equipment qualification/ verification.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- May contribute to regulatory filings.
- May conduct lab investigations as necessary.
- Evaluate lab practices for compliance on a continuous basis.
- Approve lab results
Basic Qualifications & Experience:
- At least 5 years in a cGMP regulated environment
- NPI and Method Transfer experience is a must
- Routine testing background with the technical know how, moved into project NPI/Method transfer roles
- Candidates would need to have method transfer experience and competencies we're looking for are to -develop a plan, within the plan call out individual strategies, validation/qualification etc
- Looking for a team player, able to work in a fast paced environment, influencing skills and contribute to a positive team dynamic
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
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.