Quality Specialist II

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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

When you're part of the team at Thermo Fisher Scientific, 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.

Location/Division Specific Information

This position will be based at the Thermo Fisher Scientific site located in Millersburg, PA.

How will you make an impact?

Be part of a fast-growing manufacturing site that is committed to operational excellence in manufacturing and across the supply chain. This position will be essential to enabling year over year double-digit growth by assisting with site-critical Deviation Management projects using cross functional teams.

What will you do?

• Trackwise records management and associated results.
• Review, edit and approve existing procedures. Create new SOPs as appropriate to close QMS gaps and drive continuous improvement.
• CAPA timeline management.
• Interact/lead deviation management activities within a cross-functional team.
• Investigate and perform RCA (root cause analysis) activities; cascade knowledge and work with functional department owners/leads.

How will you get here?

Education:

Minimum Requirement: HS Diploma/GED

Preferred: Associates Degree

Experience:

• 2+ years of quality management system experience.
• Experience working in a team environment
• Experience in efficiently crafting top quality work under aggressive timelines

Preferred Experience

• Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
• Ability to understand various manufacturing processes and quality processes.
• Excellent written and interpersonal skills.
• Ability to interact with/lead at 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 Schedule Planning, Meeting Minutes, Action Items & Reminder Notifications)
• Positive demeanor and confirmed communication skills
• Ability to prioritize and handle multiple projects simultaneously
• Ability to influence without authority
• Ability to develop credibility and positive professional relationships with subordinates, peers and upper management
• Proficient in Microsoft Office Applications
• Ability to travel (< 10%)

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