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Position Title: QC Associate
Supervisor Title: Quality Control Manager
Job Level (PLS): P1-P3
Position Type: FTE
Job Function: Manufacturing, Quality Control
Location: Charlottetown, PEI
Position Description: The QC Associate is responsible for supporting the Quality Control group’s qualification, validation, tech transfer and investigational activities through the preparation and performance of qualification/validation protocols in accordance with the Elanco Global Quality Standards and guidelines set forth by regularly agencies. The QC associate will additionally support the QC teams routine testing of in process and final product material, with emphasis on method remediation’s, and investigations.
Functions, Duties, Task:
The candidate must be highly skilled in running multiple projects through to completion, in a timely manner.
Method validations: Lead projects related to testing for Validations (Cleaning, methods, processes, equipment, storage and transport, etc.)
Role includes: method development, preparation/review of protocols, testing execution, data review and analysis, trouble-shooting, training QC analysts, and preparation of final reports
Work directly with other teams, such as R&D, TSMS, manufacturing and QC in troubleshooting investigations, or other projects as required.
Source and lead qualification of new QC equipment and calibration/maintenance of existing equipment.
Routine testing of In process and Final Product samples
Provide support to QC lab as an SME is a variety of techniques (molecular, microbiological)
Function as support for QC Manager, including participating in investigations, QC test review and other duties assigned by supervisor.
Ability to work within the Elanco Quality systems (Veeva, SharePoint, etc.)
Recognize, report and support OOS and deviation investigations as required
Occasional after hours work, and on-call schedule
Ability to handle non-standard requests with little oversight
Ability to prioritize activities and shift focus to respond to fluid needs
Minimum of 5 years lab experience, GMP training, microbiology or molecular biology experience is an asset
Expertise in HPLC, qPCR and ELISA methods is an asset
Ability to work independently, and lead projects
Excellent time management skills to manage various project deliverables
Strong communication skills
Proficiency with business applications such as; Adobe, MS Office, JMP, Excel, Access, Visio and PowerPoint
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status