Descripción del Trabajo
Oversee and manage the execution of Quality Systems (QS) at the site level, including the Corrective and Preventive Action (CAPA) program. Lead the compilation and analysis of QS metrics for Quality Progress Review (QPR), Quality Systems Management Review (QSMR), and other metrics. Manage a team of Document Controllers and Document Clerks and oversee the Records program.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, product quality escalation, site complaint manufacturing investigations.
- Develop and administer training programs to grow the competency of the resources at the site who execute NC, CAPA, product quality escalation, and site complaint manufacturing investigations.
- Manage on site QPR, QSMR, and other metrics reviews by championing cross-collaboration across functions, identifying barriers for progress, and elevating issues for resolution.
- Oversees on site Document Control, including change management, administration of the change control system, and daily supervision of a team of four employees.
- Serves as Records Coordinator for the site, acting as records management SME and handling archival of records both physically and electronically.
- Serves as the Backroom Lead during all audits, handling coordination of audit readiness and day of audit execution. Serve as SME for CAPA, QPR, and QSMR processes during audits.
- Lead audit observation response activities, including performing root cause analysis, writing responses, and ensuring timely completion of activities.
- Champions quality initiatives at the site, including collaboration with above site teams.
- May perform other duties and responsibilities as assigned.
- Working knowledge of CAPAs is required; technical writing, root cause analysis, and problem solving are required.
- Strong verbal and written communication skills are required.
- Strong ability to take initiative regarding innovative approaches to problem solving in a fast-paced business environment is required.
- Experience in Quality Auditing and notified body inspections is preferred.
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required. Experience with SAP and document management systems are preferred.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor’s degree in science, engineering, or another field is preferred.
- Three (3) years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is required.
- One (1) to three (3) years of supervisory experience is preferred.
- Experience with training or coaching others is required.
- Experience with root cause investigation, change management, and auditing is required.
- A certification in process excellence / lean six sigma or equivalent is preferred.