Job Description

JOB FUNCTION:

Responsible for facilitating and maintaining the Change Control, Documentation Control and Deviation Process within HPNE.

REPORTS TO: Director of Quality

PRIMARY FUNCTIONS:

· Facilitate and maintain the Change Control Process by working closely with appropriate departments to ensure initiation, follow up and closure of all change controls in a timely manner

· Chair Daily Change Control Meetings and publish Meeting Minutes

· Monitor and publish Change Control Metrics

· Facilitate and maintain the Deviation Process from initiation, follow up and closure

· Maintain the Documentation Control Process by ensuring that all controlled documents are released according to procedure and that controlled copies are available at the point of use

· Monitor the scanning, saving and filing of all Batch Records upon product release

· Completes all tasks within established guidelines

· Ensure compliance to HPNE’s Quality System and Procedures

· Must be able to work in a Team environment, multi-task and communicate effectively

· Must be able to train other employees

· Supports continuous improvement

· Other duties as assigned

COMPETENCIES:

· Minimum 3-5 years experience in related position

· Proficient in the English language (speak, read and write)

· Effective written and verbal communication skills

· Strong attention to detail

· Proficient in MS Word, MS Excel, Adobe

· Ability to read specifications, procedures, and engineering drawings

· Experience with Change Control, Documentation Control and Deviation Processes

A $500 signing bonus will be provided after the first 90 days of employment.

Company Description

High Purity New England is a distributor for more than 20 international companies and a manufacturer of our own single-use assemblies, ready-to-use systems, & bioprocess solutions for biotech, pharmaceutical, and life-science companies around the world.