Job Description
We are currently looking for a QC Senior Analyst
Duties:
- Point of contact for raw material testing (within QC and
contract Laboratory). - Coordinate and document sample shipment to Contract
Laboratory facility. - Monitor contract laboratory sample turnaround time.
- Coordinate and document result retrieval from Contract
Laboratory facility. - Review and Verify QC data.
- Generate Material Specification Reports and associated
documentation. - 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
required. - 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
Support supervisor. - Supports CAPA and change control through participation in
project planning and collaboration.
Requirements
Skills:
- 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,
fast-paced environment. - Excellent written and oral communication skills.
- Understand GMP requirements.