Quality Compliance Associate
- Job Title
- Quality Compliance Associate
- Job ID
- 27747365
- Location
- Lakewood, NJ,
- Other Location
- Description
-
Basic Job Functions:
Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Essential Functions of the Job:- Support the Annual Drug Product Review (ADPR) process.
- Support the Deviation and Change Control process.
- Support the CAPA process including initiation, closure and performance of Effectiveness Checks.
- Complete Supplier Incident Reports and follow up with vendors.
- Support site cGMP trainings as needed.
- Update packaging batch records and issue batch records for use.
- Work in the Trackwise System.
- Revise and write SOPs as needed.
- Route documents in document management system.
- Update spreadsheets and maintain departmental metrics.
- 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 knowledge of Good Documentation Practices.
- Possess a working knowledge of MS Office applications (word, excel, etc...)
- Attention to detail.
- Ability to work individually and in groups.
- Interpersonal skills.
- Ability to perform basic math 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 Compliance Associate I must have a college degree and 0-2 years of Quality Control/Assurance experience in related field and LIMS experience. The Quality Compliance Associate II must have a college degree, 2 plus years of Quality Control/Assurance experience in a related field and LIMS experience.
- Required Skills
-
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.
