• QA Specialist II - Deviation Management

    ThermoFisher Scientific (Millersburg, PA)


    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 results

    + Review, edit and approve existing procedures

    + Develop new SOPs as needed 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 or equivalent experience

    Experience:

    + 2+ years of quality management system experience

    + Experience working in a team environment

    + Experience in efficiently crafting top quality work under daring 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 communication 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 balance 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%)

     

    \#skilledmillersburg

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.