What are the responsibilities and job description for the Administrative Final Inspector position at On-Board Companies?
On-Board PMO is hiring an Administrative Final Inspector
in Hemlock!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
About Us:
On-Board PMO, Incorporated, is an on-site contract service provider for a local manufacturing entity providing full-time positions to our employees. We offer benefits, paid time off, paid holidays and 401k after a probationary time.
Position Details:
Position Type: Full Time
Job Location: Hemlock, MI
Shift: 7:30 AM – 3:30 PM M-F but Flexible with a 30-minute unpaid lunch break.
Pay rate: $20/Hour
Benefits: Eligible for complete benefits package after 60 days
Overview/Summary:
The Final Inspector for the Healthcare Industries Materials Site (HIMS) provides support to E&I’s Healthcare business, the supply chain, and quality department by reviewing and approving batch records of raw materials, intermediates, and final and externally manufactured products. These reviews are completed to assure compliance for regulatory requirements, accuracy, and completeness. Communicates and escalates any batch information that could indicate quality issues. Coordinates batch record review with delivery schedule and supply chain schedules.
As this is supporting an FDA regulated business, this role also assures QMS, and process streams meet regulatory requirements including cGMP (Good Manufacturing Practices).
What You Will do:
The main objective of the Final Inspector is to approve or reject raw materials, intermediates, final and externally produced products for the product line. This includes managing and reviewing large amounts of electronic and paper data and maintaining organized systems assuring regulatory compliance and traceability.
o Timely review of production and lab documentation (paper and electronic) to ensure compliance with regulatory requirements.
o Ensures all quality issues are documented and resolved at the time of raw material release or product approval.
o Ensures records are reviewed according to SAP inspection lot due dates to meet customer delivery date. Maintain inspection lot information in SAP to reflect accurate inspection lot status.
o Change Dates according to production timing, analyze batch where it was used. Communicates with logistics on any known delays.
o Timely completion of raw material and externally produced inspection lots by daily monitoring of the Healthcare quality functional mailbox. Entering the test data from provided COA and entering the testing results into SAP and ensure the inspection lot clears. Archive COAs in appropriate file share.
o Timely review of production labels to ensure accuracy and completeness prior to issuance to production.
o Tracks batch record error rates and charts in spreadsheet. Be able to report metrics monthly.
o Correct actual quantity errors when requested in a timely manner to prevent delays on accuracy and approval. Correct inventory, block material, transfer data between systems (SAP and Sample Manager).
o Investigate and correct any Date of Manufacture errors when requested. Make sure the Next Inspection Date is corrected to reflect any date changes made.
o Enter each completed batch into FastTrack file tracking system for record archive.
o File completed batch records timely and efficiently to their designated location.
o Provide data and metrics on overall First Pass for Quality rate.
· Good Documentation Practices
o Give training on Good Documentation Practices to new hires.
o Monitor documentation errors and communicate errors so they are corrected, and documentation meets regulatory requirements.
o Provide coaching and explanations of any errors found.
o Report metrics as needed on errors.
· Quality Management System support
o Maintain an organized system for tracking all paperwork and electronic records.
o Support quality investigations and risk assessments.
o Support internal and external audits.
o Retrieves records from HIMS Documentation Center and other documentation retention areas. Complete annual records destruction per company records retention policy.
o Maintains Final Inspection Procedures to ensure the document is accurate and reviewed on time.
· Quality Team Support
o Provides training to new final inspection team members.
o Call-in contact for final inspection if internal product approval needs arise during off business hours.
Requirements:
· High School Diploma.
· Work experience and familiarity with HIMS.
· Experience in Quality or relevant function preferred.
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest,NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 24-03085
Salary : $20
