Technical and Craft Labor - RFT Specialist, Manufacturing

When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

Job Title:

RFT Specialist, Manufacturing

Reports To:

Production Supervisor
Group/Division: SDG/MBD
Career Track:
Associate
Career Band: 1

Position Location:

Lenexa, KS
Day/Shift (if applicable):
Weekend, Fri-Sun
FLSA Status (Exempt/Non-Exempt):
Non-Exempt

Position Summary

The Right First Time Specialist (RFT) will review batch records for Good Documentation Processes (GDP) and audit production processes for Standard Operating Procedure (SOP) compliance. The RFT Specialist requires excellent attention to detail and organizational skills to ensure thorough and accurate evaluation of documentation and manufacturing processes.

Key Responsibilities

• Review Device History Records (DHRs) for compliance with cGMP good documentation requirements.

• Audit production batches according to ANSI AQL standards.

• Communicate effectively and coordinate tasks with Manufacturing and Quality Control to ensure Right First Time.

• Escalate documentation or manufacturing issues to Supervisor as required.

• Track and trend functional metrics.

• Support Regulatory and Customer Audits.

• Support continuous improvement activities and participate in lean activities.

Minimum Requirements /Qualifications

• Must be able to communicate and comprehend, both written and verbally, using the English language.

• Must be able to perform basic math.

• Must be able to lift up to 50lbs.

• Must be able to stand for sustained periods of time, approximately 10 hours per day.

• Must have ability to see and distinguish colors.

• High School Diploma or equivalent.

• Experience in manufacturing or laboratory setting.

• Working knowledge of various computer software such as Excel.

• Availability to work alternate shifts when needed.
Preferred Requirements

• 1+ years of experience in Manufacturing, QA, or QC within a regulated environment such as medical device, pharmaceutical, or food manufacturing.

• Background in Medical device, cGMP, or ISO certified environment.

• Data entry skills and familiarity with inventory management systems such as SAP.

• Demonstrated ability to work effectively as a member of a cross-functional team.
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This position has not been approved for Relocation Assistance.
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