QC Compliance & Data Review Specialist III Job Type:

Contract - 6

Months Location:

Frederick, MD Schedule:

Monday-Friday, 8:30 AM-5:00

PM Pay Rate:

$32/hour on W2 Job Overview We are seeking an experienced QC Compliance & Data Review Specialist III to support Quality Control operations in a regulated pharmaceutical or biotechnology environment. This role focuses on quality record management, independent review of GMP laboratory data, data integrity, and inspection readiness. Key Responsibilities Manage quality records, including deviations, laboratory investigations, CAPAs, change controls, and effectiveness checks. Perform independent reviews of GMP laboratory data, test worksheets, calculations, instrument outputs, and electronic records. Ensure data integrity and compliance with ALCOA+ principles, cGMP, and Good Documentation Practices. Identify documentation gaps, discrepancies, atypical results, and potential data integrity concerns. Review Certificates of Analysis (COAs), product release data packages, stability data, and OOS/OOT investigations, as applicable. Maintain compliance trackers, metrics, dashboards, and trend reports. Support internal audits, regulatory inspections, and inspection-readiness activities. Author and revise SOPs, work instructions, forms, and technical reports. Collaborate with QC Operations, Quality Assurance, Manufacturing, and cross-functional teams to resolve compliance issues. Support root cause analysis, risk assessments, CAPA effectiveness reviews, and continuous improvement initiatives. Required Qualifications Master's degree in a relevant scientific or technical discipline with 3+ years of relevant experience; OR Bachelor's degree in a relevant scientific or technical discipline with 5+ years of relevant experience; OR High school diploma or equivalent with 9+ years of relevant experience. Experience in pharmaceutical, biotechnology, biologics, cell therapy, or another regulated GMP environment. Hands-on experience reviewing GMP laboratory data and managing or supporting deviations, investigations, CAPAs, and change controls. Strong knowledge of cGMP, Good Documentation Practices, ALCOA+ principles, and 21 CFR Parts 11, 210, and 211. Experience with electronic Quality Management Systems (QMS), document management systems, and Laboratory Information Management Systems (LIMS). Proficiency in Microsoft Word, Excel, and PowerPoint. Strong analytical, organizational, documentation, and communication skills. Preferred Qualifications Experience in commercial cell therapy or biologics Quality Control. Experience reviewing analytical or microbiological data for product release, stability, environmental monitoring, or in-process testing. Familiarity with Veeva, TrackWise, GVault, LabVantage, or similar quality systems. Experience with OOS/OOT investigations, root cause analysis, and CAPA management. Experience preparing compliance metrics, dashboards, and inspection-ready documentation.

Contract Details:

6 months | Frederick, MD | $32/hour on W2 | Monday-Friday, 8:30 AM-5:00 PM SNR8 #IND2

Pay:

$30.00 - $32.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance Application Question(s): Are you a US Citizen or GCH? If on Visa please mention the Visa Status Are you ready for background check and drug screen in accordance with the local law and regulations?

• Are you ok with following Shift (First Shift) Do you have hands-on experience reviewing GMP laboratory data and ensuring data integrity in a pharmaceutical, biotechnology, or biologics environment? . Do you have experience managing or supporting quality records, including deviations, CAPAs, change controls, and laboratory investigations? . Are you comfortable working onsite in Frederick, MD, Monday-Friday, 8:30 AM-5:00 PM? Please confirm your email address and contact number? Cube Hub payroll is "Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy? What is your Expected Pay Range? What is a good time to contact you?

Work Location:

In person