Quality Documentation Review
The Fountain Group · Clayton, NC · 3 wk ago
On-siteOTHR$20–$23/hrContract
Responsibilities
- Review electronic batch records and manufacturing documentation to support batch release activities.
- Perform Quality review of documentation associated with Fractionation, Purification, Filling, and Packaging operations.
- Identify documentation discrepancies, missing information, and compliance issues during electronic record review.
- Complete area-specific electronic document review following established Quality procedures and training.
- Support additional Quality documentation and office-related activities as assigned by management.
Requirements
- High School Diploma or equivalent required.
- Associate’s or Bachelor’s degree in Life Sciences, Chemistry, Biology, Pharmacy, or a related field preferred.
Qualifications
- Electronic Batch Record (EBR) review
- Batch release documentation
- Quality documentation review
- Manufacturing record review
- GMP documentation
- Pharmaceutical/biopharmaceutical manufacturing documentation
- Quality review of Fractionation, Purification, Filling, or Packaging records
Skills
- Experience with electronic quality management systems (eQMS)
- Experience reviewing electronic manufacturing records
- Experience supporting GMP batch release activities
- Experience in pharmaceutical or biopharmaceutical manufacturing environments
Pay
Pay Rate: $20-$23/hour; Duration: 1 year