Work Schedule

Standard (Mon-Fri)

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

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

Join Thermo Fisher Scientific to contribute to finding cures, protecting the environment, and ensuring food safety—all while advancing your career.

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 quality in manufacturing and across the supply chain. This position will be crucial 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 resultsReview, edit and approve existing proceduresDevelop new SOPs as needed to close QMS gaps and drive continuous improvementCAPA timeline managementInteract/lead deviation management activities within a cross-functional teamInvestigate 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/GEDPreferred: Associates Degree or equivalent experience

Experience:2+ years of quality management system experienceExperience working in a team environmentExperience in efficiently crafting top quality work under daring timelines

Preferred ExperienceStrong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485)Ability to understand various manufacturing processes and quality processesExcellent written and communication skillsAbility to interact with/lead at all levels of the organizationDevelop and implement proceduresAbility to perform investigative processes as well as critical thinking and problem solvingKnowledge of statistical based computer programs such as Excel and/or Minitab, as well as Microsoft OfficeStrong Root Cause/Problem Solving skills

Knowledge, Skills, AbilitiesDetail OrientedKnowledge of Schedule Planning, Meeting Minutes, Action Items & Reminder NotificationsPositive demeanor and confirmed communication skillsAbility to prioritize and balance multiple projects simultaneouslyAbility to influence without authorityAbility to develop credibility and positive professional relationships with subordinates, peers and upper managementProficient in Microsoft Office ApplicationsAbility to travel (