Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Quality Specialist III (Deviation Management)
When you're part of the team, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
How will you make an impact
Become part of a fast-growing manufacturing site that is committed to operational excellence in manufacturing and across the supply chain. This position will be crucial to enabling year over year double-digit growth by coordinating site-critical Deviation Management projects using cross functional teams.
What will you do
Site Steward for Trackwise
Trackwise records management and associated results.
Collect, analyze and present site critical metric data via appropriate channels (e.g. CAPA Review Board, Management Review, Tier Cascade)
Track and trend process and product performance data to drive process and program performance.
Review, edit and approve existing procedures.
Build new SOPs as appropriate to close QMS gaps and drive continuous improvement.
CAPA timeline management.
CAPA Improvement
Investigate and perform RCA (root cause analysis) activities; cascade knowledge and work with functional department owners/leads.
Interact/lead deviation management activities as a cross-functional team.
How will you get here
Education
Bachelor's Degree required
Experience
5+ years of quality management system experience.
Ability to understand various Quality management system processes including ISO 13485 and CFR820.
Excellent communication and mentor/guiding skills.
Preferred Experience
Strong shown understanding of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
Understanding of various manufacturing processes and quality processes.
Excellent written and interpersonal skills.
Ability to work well with/lead all levels of the organization.
Develop and implement procedures.
Ability to perform investigative processes as well as critical thinking and problem solving.
Knowledge of statistical based computer programs such as Excel and/or Minitab, as well as Microsoft Office.
Ability to prioritize and run multiple projects simultaneously
Ability to influence without authority
Ability to develop high levels of credibility and forge validated and positive professional relationships with subordinates, peers and upper management
Proficient in Microsoft Office Applications
Ability to travel (< 10%)
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one distributed team of 140,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, address sophisticated scientific challenges, drive technological innovation and support patients in need.
