- The QA Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures.
- They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with relevant quality standards, relevant regulatory councils, and other regulatory requirements and perform administrative tasks..
- 6-9 Years’ experience
- Scientific or technical background (Highly Preferred)– some of the projects will be very technical and the more experience in this area would mean the less oversight we would need to provide.
- Must have strong Word and Excel skills.
- Must have strong attention to detail, several of the projects will involve a large amount of data entry and review.
- Experience in Quality Assurance/Control in a regulated industry is a major plus.
- Experience with electronic document management systems
- Experience reviewing/auditing documents from a quality perspective.
- Experience with computerized system validations
- This role will be a combination of remote and onsite