Job Title:

Quality Documentation Review Specialist Location:

Clayton, NC 27520 (100% Onsite) Pay rate: $20.00/hr

•$23.00/hr (Depending on experience) Work schedule: 1st

Shift:

Monday

•Friday, 8-hour workday with core hours between 9:00 AM

•3:00 PM EST (40.0 hours/week; occasional overtime possible but not mandatory) Overview The Quality Documentation Review Specialist performs comprehensive review of electronic batch records (eBR) to support lot release operations at the Clayton, NC manufacturing facility. Positioned within the Quality Assurance team, this role verifies production records across key operational units—including Fractionation, Purification, Filling, and Packaging—to ensure compliance with cGMP standards, FDA regulations, and standard operating procedures. The candidate receives specialized training on electronic document review and provides administrative quality support as directed by management. Job Specifications Perform detailed quality review and verification of electronic batch records (eBR) and manufacturing documentation across Fractionation, Purification, Filling, and Packaging operations Audit production logs, batch records, and quality documentation for accuracy, completeness, and adherence to cGMP and FDA guidelines Collaborate with manufacturing and quality teams to resolve documentation discrepancies and expedite product batch release Utilize electronic document management systems and automated quality databases to record, track, and archive batch review status Support general office, administrative, and quality compliance tasks as requested by quality department leadership High School Diploma or GED required; Associate or Bachelor's degree in a scientific or technical discipline preferred Prior experience with quality documentation review, batch record review, or document control within a cGMP, pharmaceutical, biotechnology, or FDA-regulated facility preferred Exposure to electronic batch record (eBR) platforms or electronic document management systems (EDMS) preferred Strong attention to detail, accuracy, and organizational skills required Proficiency with Microsoft Office Suite (Word, Excel, Outlook) and standard office computer applications required Benefits (employee contribution): Health insurance Health savings account Dental insurance Vision insurance Flexible spending accounts Life insurance Retirement plan All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant. #IND0926