We are currently looking for a QC Senior Analyst
- Point of contact for raw material testing (within QC and
- Coordinate and document sample shipment to Contract
- Monitor contract laboratory sample turnaround time.
- Coordinate and document result retrieval from Contract
- Review and Verify QC data.
- Generate Material Specification Reports and associated
- Generate CoA's for raw materials.
- Investigate and determine Root Cause associated with
laboratory deviations and investigations.
- Compile trend analysis and write associated reports for
internal and regulatory.
- Manage, communicate and document compendia updates as
- Author/revise and contribute to test methods; SOPs;
Material Specification Reports; protocols, technical studies and/or reports.
- Generate SOP's/other documentation as applicable.
- Performing all task as per GMP requirements.
- Assist in additional duties as directed by the QC Lab
- Supports CAPA and change control through participation in
project planning and collaboration.
- Ability to develop collaborative relationships with other
functions and sites in order to achieve functional, site and company goals.
- Excellent problem solving and root cause analysis skills.
- Routinely takes an innovative approach in developing
processes and procedures that are both efficient and compliant.
- Strong organizational skills.
- Planning/scheduling of own work and that of a team An
ability to work independently, as well as a member of a team in a dynamic,
- Excellent written and oral communication skills.
- Understand GMP requirements.