Technical and Craft Labor - RFT Specialist, Manufacturing

RFT Specialist, Manufacturing

Report To: Production Supervisor

Pay: Not specified

Site Location: Building 1 Lenexa Thermo Fisher Scientific 12076 Santa Fe Trail Drive Lenexa, Kansas 66215

Hours/Shift: See below

Interview Process: Supervisor would be main point of contact for scheduling and hiring, and either Isabel or Lupe will be in on the interview, will be set up for in person interviews.

Requisitions (5 total) - Manager: Lupe Ocampo Shift: (Tubes, Weekdays) Mon-Thu 6:00AM-4:30PM

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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

APPLY TODAY!