Entry Level : QS Associate (for new college grads!)

POSITION DESCRIPTION:  Provide general support to the operation of the Quality Systems department.  Supports applicable regulations including ISO, Local, State, and/or Federal requirements.

? Perform incoming inspection of raw materials to pre-defined specification.

 

? Initiate nonconforming material reports and deviations associated with incoming inspection and process monitoring documentation.

 

? Notify management, Production, Inventory Control, and other departments as necessary of inspection failures.

 

? Work with Purchasing department and suppliers to mediate quality issues and resolve nonconformities.

 

? Complete inspection documentation such as raw material specifications, status labels, and inspection checklists.

 

? Input inspection data into database system.

 

? Schedule workflow to ensure raw materials release does not negatively impact production schedules.

 

? Coordinate with the CALMAN designee to maintain monthly status list of equipment being monitoring.

 

? Review and approve monthly process monitoring charts for accuracy and completeness.

 

? Develop and publish weekly incoming inspection reports that detail status and inspection turn-around-times for raw materials.

 

? Conduct internal and external audits.

 

? Maintain controlled procedure and forms related to incoming inspection and process monitoring.

 

? Conduct inspection and complete documentation within GxP requirements such as GDPs and GMPs.

 

? Process training records and document change requests using Master Control software.

 

? Maintain disaster recovery files and historical records for Document Control.

 

? Format and word-process documents submitted to Document Control.

 

? Vacation replacement for Quality Systems Assistant.

 

? Work with Purchasing, Manufacturing, and Quality Control to maintain accuracy and completeness of raw material specifications and approved vendor list.

 

 

EDUCATION/EXPERIENCE:  Must have Associates degree in life science or engineering technology or related discipline.  Ability to type 55-60 wpm.  Must have good interpersonal communication skills.  Must be PC literate with advanced Microsoft Word and Excel skills. Access and PowerPoint helpful.  Ability to understand temperature charts and equipment data printouts used to monitor manufacturing and testing processes.  Must have knowledge of GxP requirements such as GDPs and GMPs.  Ability to understand and apply sampling plans and techniques.  Must have understanding and experience with using inspection tools such as micrometers, calipers, ruler, etc.