Careers

Basic Job Functions:

Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications. 

Annual Salary:

• $65K-$80K

Essential Functions of the Job:

·       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.