This position provides Quality Assurance support for Operations, Supply Chain, and Quality Control Laboratories. Provides QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents. Leads teams using trend and investigational data to create value through process improvements and failure reduction activities. The Quality Engineer I must act independently to identify failure modes and related process improvements, facilitating teams and working to implement required changes.
ESSENTIAL AREAS OF RESPONSIBILITY
Interacts closely with Quality Systems, Operations, Process Technology, Supply Chain, and Lab Management to provide an independent Quality Assurance presence to ensure a thorough and timely review and approval of GMP documents and processes.
Reviews and approves of any of the following:
- Master Production Records and Forms
- Minor deviations and laboratory investigations
- Change Control Documentation
- Standard Operating Procedures
Additional responsibilities include:
- Manage timely completion of complex and critical deviation reports
- Provide assessments/investigations to support customer complaints
- Complete special reports and risk assessments
- Complete CAPA and Effectiveness Checks
- Uses data trends to work with operating departments to facilitate process improvements and lean concepts
- Participates in cross functional improvement and process monitoring teams to mitigate unfavorable trends
- Works with compliance to support scheduled and unscheduled audits of operational areas
- Provides first response for Quality and Compliance issues on the manufacturing floor
Receives minimal supervision for most assignments. Receives general instructions for non-standard analyses and projects. Data analysis is complex and requires input from multiple sources and innovative problem-solving. Interfaces to negotiate and exchange information with all levels of management. Performs other duties as assigned.
- A Bachelor’s Degree in Science or Engineering with at least 3 years of QA experience in the Pharmaceutical related industry, or equivalent.
- Experience with management of partner relationships preferred
- Experience with the handling of deviations, investigations, and CAPAs required
- Excellent computer systems and MS Office skills with working knowledge of computer relational databases.
- Detail oriented, team player with strong interpersonal skills.
- Demonstrated working knowledge of cGMP and applicable regulatory requirements..
- ASQ CQE/CQA certification a plus
- Detailed knowledge and experience of applicable processes, quality systems, validation, investigation review.
- Sound background/understanding of applied statistics
- Experience with Trackwise, SAP, LIMS/Labware and Statistical Software a plus
- Proven ability to work in a team environment through conflict resolution and negotiations.
- Excellent written and verbal communication skills.
Manufacturing Quality Assurance
Associate Director Operational QA/Quality Systems