The Senior Quality Engineer will support the quality assurance QC testing Laboratories. The position supports laboratory operations including test method development and validation, compendial verification, laboratory investigations, equipment qualification, compliance metrics, and regulatory compliance including regulatory filings and data integrity.
This position will work primarily with QC laboratory staff and leadership as well as with other Quality Engineers to provide sustaining quality and compliance leadership.
Responsible for the assisting with GMP compliance of all functions and processes of the QC Chemistry and Microbiology departments and drive continuous improvement.
Support transfer of analytical methods and specifications for new products to the QC laboratories.
Provide analytical testing expertise and guidance, particularly when addressing laboratory investigations.
Review and approval of analytical investigations (LIRs), non-conformances (NCs), and Corrective/Preventive actions (CAPA) ensuring compliance to site procedures and cGMP.
Review/approve validation and qualification protocols and reports.
Review/approve QC laboratory SOPs on behalf of Quality Assurance.
Assist the QC laboratories in identifying and implementing actions to improve on-time delivery, right first time, improve process efficiency.
Assist the laboratories in implementing and maintaining data integrity initiatives and procedures.
Monitor and report on timely completion of quality system records.
As assigned, represent the Quality Manager on project teams and implementation of continuous improvement efforts within the department and across the site.
Assist functional areas with systematic problem-solving methodologies when resolving quality issues.
Other duties as assigned
BS in Chemistry, Biology, or a closely related field.
A combination of education and experience will be considered.
Special Skills: Quality Engineering training in statistics, validation, and working knowledge of QC laboratory operations. Ability to work independently. Knowledge of current regulatory requirements related to data integrity is strongly preferred.