Lead Protein Controlled Room Technician (Fraser, MI)

Job Overview

The primary purpose of this position is to assist and oversee the Protein Controlled Room in preparation of various Protein Free tests, duties, and technicians.

Job Responsibilities and Essential Duties:

• Follow all applicable procedures, work instructions, and policies.
• Use SAP program to transfer items into the department.
• Maintain inventory.
• Keep track of lot numbers for all items in the department.
• Train new employees in the Protein Controlled Room.
• Help prioritize workflow as needed.
• Bead Vial filling.
• Dispensing Protein Free Tests.
• Packaging Protein Free Tests.
• Proper Labeling Handling.
• Vial Preparation (Filling with water, emptying, drying).
• Activator Preparation.
• QC Sonochecks
• Bead Preparation
• Activator Capping.
• HC-Swab Manufacturing.
• Proper paperwork handling.
• All other duties as deemed necessary.
• To Oversee:
  
  
  
  • Oversee the preparation of bead vial filling, dispensing protein free tests, packaging free tests, vial preparation, activator preparation, and activator capping.
  • Maintain the completion of Article History Records (AHR) for the products manufactured.
  • Enforce all applicable procedures, work instructions, and policies in the Protein Controlled department.
  
  
  
  

Required Knowledge, Skills and Abilities:

• Skill and proficiency in using personal computer software programs including word processing and spreadsheet applications.
• Good organizational skills.
• Basic Math skills.
• Team player with a positive attitude.
• Employee must be able to perform all tasks listed.
• Tasks must be completed in an efficient and time-sensitive manner.
• Equipment used: Computer, Label Printer, Copier, Crimping robot, Water Robot, Torque Gun, Honey extractor, Bead sieve shaker, Cap Trays, Vial Trays, Bins, Accellos Program, Dispensers.

Minimum Requirements:

• High School Diploma or equivalent.
• Ability to read and understand written and verbal job instructions and procedures.
• Attention to detail and high level of accuracy.

Quality Requirements:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

• Available to work overtime and weekends as needed.
• Able to lift 45 lbs. unassisted.
• Able to bend, stoop and lift overhead.
• Able to sit or stand for longer periods of time.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Monday-Friday, 7:30am-4:00pm

$22.25-$27.70/hour depending on experience and location