Quality Systems Engineer

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:

Comply with all company policies, SOP's, current Good Manufacturing Practices and other relevant regulatory requirements.
Maintain training at or above 90% of assigned curriculum.
Possess Good Documentation Practices.
Possess a working knowledge of MS Office applications (word, excel, etc. )
Possess a working knowledge of Statistical Programs or equivalent, such as SPC, Minitab, Jasq, etc.
Possess a working knowledge of LIMS or equivalent.
Attention to detail.
Ability to work individually and in groups.
Interpersonal skills.
Ability to read, write and understand English.
Effective communication skills.
Meet deadlines as assigned.

Physical Requirements:

Walking within the confines of the facility.

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.
Required Skills
Essential Functions of the Job: