What are the responsibilities and job description for the Quality Compliance Associate position at Accupac?
Basic Job Functions:
Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Essential Functions of the Job:
Minimum Requirements of the Job:
Physical Requirements:
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.
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.
