Quality Specialist III
at Thermo Fisher Scientific
Millersburg, PA 17061, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 28 Dec, 2024 | Not Specified | 02 Oct, 2024 | N/A | Research,Manufacturing Processes,Minitab,Schedule Planning,Interpersonal Skills,Iso,Quality Processes,Microsoft Office,Technological Innovation,Critical Thinking,Excel | No | No |
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Full Time | Part Time |
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Description:
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 Oriented
- Knowledge of Project Management Tools – Schedule Planning (Gantt charts / 4-blockers) and Task Tracking (Meeting Minutes, Action Items & Reminder Notifications)
- Positive demeanor and shown social skills
- 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.
Apply today! http://jobs.thermofisher.com
Responsibilities:
- 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.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Information Technology/IT
Pharma / Biotech / Healthcare / Medical / R&D
Software Testing
Graduate
Proficient
1
Millersburg, PA 17061, USA