Share this Job

 

 

 

 

Title:  Quality Validation/Control Analyst I

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE: Senior Manager, QA Validation

 

PURPOSE OF POSITION:  The Quality Validation/Control Analyst I’s main responsibilities are to perform general laboratory activities and environmental monitoring of clean room and utility systems.  This position also provides Quality oversight of facilities, utilities and equipment documentation and qualifications in a cGMP environment. Assists in defining requirements, which may include: cleanrooms, utilities, facilities and equipment. The position will review and approve equipment documentation and environmental monitoring data, as well as, data entry of protocols/reports/preventative maintenance. Additional responsibilities may include conducting internal audits and training.

 

QUALIFICATIONS

 

 

Required:

  • Bachelor’s Degree in Science or Engineering discipline; or
  • Education/experience equivalent

Preferred:

  • N/A

Skills & Competencies:

  • Possess a good balance of laboratory expertise, analytical thinking and communication skills for resolving issues internal and external to the organization.
  • Competent with word processing, spreadsheet (preferably Word, and Excel)
  • Able to follow and execute protocols

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. 
  • Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time
  • Ability to operate lab instrumentation and equipment

RESPONSIBILITIES:

  • General laboratory activities including but not limited to, sample receipt, inventory control, testing, equipment and instrument operation/maintenance.
  • Performs everyday laboratory requirements which includes: cleaning, maintenance, ordering of supplies, and maintains adequate inventory of supplies needed for all microbiological testing
  • Schedules and Tracks Calibration and Metrology Activities.
  • Schedules and executes environmental monitoring of clean room and utility systems using a variety of testing tools and measuring equipment (HVAC and CDA).
  • Review and approve equipment documentation and environmental monitoring data, as well as, data entry of protocols/reports/preventative maintenance.

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati