What are the responsibilities and job description for the Quality Systems Engineer position at Accupac?
Job Description
Job Description
Basic Job Functions :
Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Essential Job Functions :
- Support the Annual Drug Product Review (ADPR) process.
- Support the Deviation process including initiation and closure of records.
- Support the Change Control process including initiation and closure of records.
- Support the CAPA process including initiation, review, and closure of records.
- Perform Effectiveness Checks with the use of Statistics when applicable.
- Working closely with Quality Laboratory Systems group and Manufacturing Engineering group to track and enhance current processes through use of Statistical processes.
- Perform cGMP adherence walk-throughs as needed for the site.
- Work in the Trackwise System.
- Update spreadsheets and main departmental and customer metrics, including but not limited to, Quality Management Meetings, CAPAs, Training, Change Controls, Deviations, etc..
- Revise and write SOPs as needed.
- Perform other duties as assigned.
Minimum Requirements of the Job :
Physical Requirements :
Supervisory Responsibilities : No
Travel : None
Education and / or Experience : The Quality Systems Engineer I must have an Engineering college degree or equivalent and at least 0-2 years of Quality Control / Assurance experience in related field, as well as LIMS experience. The Quality Systems Engineer II must have an Engineering college degree (Master’s preferable), and 3 plus years of Quality Control / Assurance experience in a related field, as well as LIMS experience. Having a Quality Engineer (CQE) certification or equivalent can be applied as time and experience.
