الوصف الوظيفي
Piper Companies is looking for a QA Analyst to join a cGMP-regulated pharmaceutical manufacturing company located onsite in Silver Spring, MD.
Responsibilities of the QA Analyst include:
• Reviewing and approving GMP documents such as IOQ/PQ protocols, stability and operational protocols, reports, and other documentation supporting intermediates, APIs, and drug products
• Supporting and/or leading quality events and investigations, including deviations, OOS results, alerts, CAPAs, change controls, and effectiveness checks
• Creating or assisting with Master Batch Records, SOPs, protocols, summary reports, and raw material specifications
• Contributing to process and manufacturing documentation, including material specifications, drawings, Site Master Files, AQRs, inspection procedures, and manufacturing procedures
• Supporting Quality Systems improvements and providing on-the-floor QA coverage during cGMP operations (approx. 20%)
• Assisting with regulatory inspection preparation and audit response activities
• Supporting CMO-related work such as process reviews, investigations, change evaluations, and new project activities
• Partnering with project management to track timelines and maintain progress
• Collecting data and providing technical support for external partners
Qualifications for the QA Analyst include:
• Bachelor’s degree with 2+ years of pharmaceutical cGMP experience, or Master’s degree with 1+ year
• Minimum 2 years of experience in Quality Assurance, Quality Engineering, or Validation
• Strong knowledge of cGMP and documentation practices
• Experience with investigations, CAPA processes, and change control (preferred)
Compensation for the QA Analyst includes:
• Rate Range: $35-45/hr
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
This job is open for applications on February 11th, 2026. Applications will be accepted for at least 30 days from the posting date.
Keywords: QA Analyst, Quality Assurance, Quality Systems, cGMP Compliance, GMP Documentation, Pharmaceutical Manufacturing, Batch Record Review, Master Batch Records, SOP Development, IOQ/PQ, Protocol Review, Process Validation, Cleaning Validation, Equipment Qualification, Change Control, CAPA Management, Deviation Investigation, OOS Investigation, Root Cause Analysis, Effectiveness Checks, Quality Events, Quality Engineering, Document Control, Raw Material Specifications, Site Master File, AQR, Regulatory Compliance, FDA Regulations, MHRA Inspections, Audit Support, Internal Audits, External Audits, CMO Support, Contract Manufacturing Oversight, Technical Documentation, Data Collection, Stability Protocols, API Manufacturing, Drug Product Manufacturing, Manufacturing Support, On-the-Floor QA, Inspection Procedures, Material Specifications, Risk Assessment, GMP Training, Quality Metrics, Quality Risk Management, Pharma Quality Validation, cGMP Operations