Job Title: Quality Specialist
Department: GMP Quality
Reports To: Director GMP Quality
Classification: Full-time, Non-exempt
Date: June 1, 2022
Avance Biosciences™ Inc., a fast-growing biotechnology CRO, is recruiting several employees in its GLP and GMP an Quality Departments. This position assists in maintaining our Quality Management System Also, this position performs in accordance with company’s established SOPs to support our customers’ drug discovery, development, and manufacturing activities.
Essential Duties and Responsibilities
The omission of specific statement of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class. Duties, responsibilities, and activities may change at any time with or without notice.
- Perform quality system procedures to ensure compliance with internal SOP’s and US FDA regulatory requirements including 21 CFR Part 210 and 211, 21 CFR Part 11, and other relevant guidelines and publications.
- Responsible for releasing reagents
- Review laboratory documents including cleaning and use loges, temperature monitoring records, equipment records, etc.
- Keep track of the training status of employees
- Assist in the document change control process
- Assist with internal and client audits and regulatory inspections
- Assist in the vendor assessment process
- Responsible for tasks assigned by the supervisor
- Strong organizational skills
- Strong written and verbal communication skills
- Ability to function in a team atmosphere
- Experience with MS Word and Excel and general knowledge of databases
- BA/BS in a biological or chemical
- Understanding of GMP/GLP compliance