Calibration and RMA Coordinator - Simply Biotech

Calibration and RMA Coordinator- Simply Biotech

Overview

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.

Immediate opening for a Calibration and RMA Coordinator with a biotech company in Aliso Viejo, CA who possesses:

• 1 years of experience with RMAs
• Calibration experience highly desired
• Must have experience in a highly regulated industry - Medical, Defense, or Aerospace
  
  

Email resumes to mlowe@simplybiotech.com or call 858.225.4141

FULL DESCRIPTION: Assist in equipment/calibration program and repair device RMAs. Assists in equipment qualifications and re-qualifications, as needed. This position will provide support to coordinate or work with equipment owners and suppliers to troubleshoot and resolve equipment issues. Support the equipment and process validations. Work with Product Development, Manufacturing, and Quality Control departments to ensure product quality and regulatory compliance. Performs quality functions to support ISO 13485, FDA, CGMP, Quality System Regulations, management reporting, production/QA/QC, process development, manufacturing transfer, and facility support as required. Provide support during audits.

The Selected Candidate Will Be Responsible For

• Monitors and maintains laboratory and engineering equipment to ensure preventive maintenance and calibration program compliance, including budgets and POs.
• Updates equipment processes to ensure compliance with latest requirements and to streamline processes wherever possible.
• Reviews and understands quality regulations for audits, compliance, and implementation.
• Revises and formats Quality System controlled documentation, including procedures, forms, and engineering documents.
• Supports validations, performs testing, and updates QA/QC/process documentation.
• Provide support in updating MVP and the associated documents
• Co-Owner of DicksonOne system and all associated loggers
• Co-Owner of XTrak system with USCalibration
• Monitors and maintains the environmental monitoring program for the cleanrooms.
• Other administrative duties as required, including printing labels, maintaining logbooks, maintaining environmental logbooks, etc.
• Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release.
• Review test results and release material for use
• Responsible for assisting the Quality Assurance team with any ad hoc reports and assignments as required.
• Performs in-process, final, or incoming inspections as required.
• Reviews repair device Batch Records
• Supports RMA-repair device
• Write and review material review board dispositions within the functional area.
• Maintain working knowledge of all U.S. and International standards relating to medical devices including biocompatibility, physicochemical, optical mechanical, IEC/EMC, ISO, etc. for the company as required.
• Other responsibilities as defined by the Senior Quality Operations Manager- repair device.
  
  

The Selected Candidate Will Also Possess

• Knowledgeable of equipment and calibration of equipment
• Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11
• Knowledgeable of ISO 13485
• Bachelor's degree or a combination of education and experience.
• Microsoft Word; Microsoft Excel.
• QAD experience a plus
• Training to be completed per the training plan for this position as maintained in the document control system
• The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis
  
  

Salary Range: $20-$25/hr

For immediate and confidential consideration, please email your resume to mlowe@simplybiotech.com or call 858.225.4141. More information can be found at www.simplybiotech.com