Work Schedule

First Shift (Days)

Environmental Conditions

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 TrackwiseTrackwise 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 ImprovementInvestigate 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.Strong Root Cause/Problem Solving skills

Knowledge, Skills, Abilities

Detail OrientedKnowledge of Project Management Tools – Schedule Planning (Gantt charts / 4-blockers) and Task Tracking (Meeting Minutes, Action Items & Reminder Notifications)Positive demeanor and shown social skillsAbility to prioritize and run multiple projects simultaneouslyAbility to influence without authorityAbility to develop high levels of credibility and forge validated and positive professional relationships with subordinates, peers and upper managementProficient in Microsoft Office ApplicationsAbility to travel (