Quality Specialist II - 2nd Shift

Quality Specialist II - 2nd Shift

Second shift: 2:00 pm to 10:00 pm - 10% shift differential

Biosciences Division / Milwaukee, WI

How will you make an impact?

The primary goal of the Quality Specialist II position is to maintain and continually improve the quality management systems of the site to achieve the proper balance between fulfilling customer needs and business objectives.

What will you do?

  • Provide Quality review of investigations, deviations, change controls, validation protocol and reports (IQ/OQ/PQs), SOPs, and in-process controls in support of manufacturing

  • Investigate complaints from internal and/or external customers to resolution in a timely manner

  • Investigate, analyze and correct non-conformances (internal, external and systemic issues)

  • Provide training to associates, foster achievement of goals as coach for team members and act as role model in implementation and improvement of practices/procedures

  • Work as a member of New Product Introduction teams, assuring design quality elements are maintained and compliant with applicable regulations

  • Analyze trends and collaborate with Manufacturing to investigate trends, conduct root cause analysis and assist with corrective actions for processes and products, ensuring their effectiveness

  • Collect, analyze, and present Quality data to create and implement projects for improvement

  • Create quality documents aligned to QMS standards and practices, revises quality documentation to better define, improve, or clarify practices, process and/or product quality

  • Participate as internal auditor for ISO 9001, and participate in external audits

  • Support and actively participates in the continuous improvement processes.

  • Other duties apparent or assigned

How will you get here?

Education:

  • BS in Biology, Chemistry, Biochemistry, or a related science required

  • Minimum required education: Bachelor degree and High School Diploma/GED

Experience

  • Minimum of 2 years of experience in operational and/or quality assurance position in a manufacturing organization

  • Makes good judgments and decisions and provides proper advice on issues of work product quality nature and/or QMS compliance

  • Must be self-motivated, proactive, organized, and detail oriented

  • Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet both QMS and business requirements

  • Ability to effectively organize and present information to groups of employees, site leadership, and customers

  • Understanding of ISO9001 or equivalent quality system principles

  • Ability in the use of electronic systems (e.g., computer) and MS office (Word, Excel) knowledge

  • Auditor Certification (CQA) a plus

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Posted
10/04/2021
Salary Range
$52,000.00 - 84,000.00
per Year
Salary range estimated by
Location
Milwaukee, WI 53244, US
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