QC Compliance

Job Title: Quality Control Research Associate

Location: Frederick, MD 21704
Duration: 6-month contract
Schedule: Monday–Friday, 8:30 AM–5:00 PM
Pay Rate: $36.56/hour (W2)

Job Summary

We are seeking a detail-oriented Quality Control Research Associate to support QC compliance, laboratory data review, and quality documentation in a regulated pharmaceutical or biotechnology environment. The role focuses on data integrity, compliance records, investigation support, and inspection readiness.

Key Responsibilities

• Review laboratory data, test results, calculations, and electronic records for accuracy, completeness, and compliance.
• Manage and review quality records, including deviations, CAPAs, change controls, and laboratory investigations.
• Ensure documentation complies with Good Documentation Practices (GDP), cGMP, and data integrity principles.
• Identify discrepancies, investigate documentation gaps, and escalate compliance concerns.
• Maintain compliance trackers, metrics, and reports to support quality performance monitoring.
• Review SOPs, work instructions, and technical documentation.
• Support audits, inspections, continuous improvement initiatives, and cross-functional quality activities.

Required Qualifications

• Master's degree in a relevant scientific or technical discipline with 3+ years of relevant experience; OR bachelor's degree with 5+ years; OR high school diploma/GED with 9+ years in a regulated GMP environment.
• Experience reviewing laboratory data and supporting deviations, investigations, CAPAs, and change controls.
• Knowledge of cGMP, GDP, data integrity, and root cause analysis.
• Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
• Strong analytical, documentation, communication, and problem-solving skills.
• Experience with electronic quality management systems is preferred.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, biologics, or cell therapy environments.
• Familiarity with quality management systems such as Veeva, Track Wise, or similar platforms.
• Experience with laboratory data review, audit readiness, and quality metrics.