Principal Quality Assurance Specialist

Principal Quality Assurance Specialist Bethlehem, PA Job Details $85,000 - $95,000 a year 1 hour ago Qualifications Quality control corrective actions Regulatory inspections Record keeping Document review (document control) 7 years Audit report preparation Pharmaceutical regulatory compliance Writing skills Compliance audits & assessments Corrective and preventive actions (CAPA) GMP Complaint handling Quality control documentation Batch records Pharmaceutical plant experience Document archiving Quality audits Quality assurance within manufacturing Root cause analysis Senior level Training Cross-functional collaboration Document management systems Communication skills Cross-functional communication Full Job Description Senior Quality Assurance Compliance Specialist (GMP Compliance) Day Shift | $85,000-$95,000 base + bonus | Excellent benefits Our client is a global pharmaceutical manufacturer supporting life-saving critical care products. Due to continued growth, they are hiring a Senior Quality Assurance Compliance Specialist to support GMP operations, documentation, and quality systems in a regulated manufacturing environment.

Key Responsibilities:

Review and disposition finished product and provide final CoA approval/signature Lead and support deviation investigations , CAPAs, and change controls Ensure timely closure of non-conformances with strong root cause analysis Review and approve laboratory investigations Support regulatory inspections and internal/external audits Perform internal audits and assist with audit report writing Support and maintain document control systems (eDMS), including document routing and archival Review/approve SOPs, BOMs, inspection plans, calibration records, and quality documentation Support APR activities, trend reporting, and quality metrics Maintain vendor complaint process and supplier approval program Provide training support and guidance to QA team members Occasional travel up to 25%

Qualifications:

7+ years Quality Assurance experience in a GMP pharmaceutical manufacturing environment Strong experience with deviations, CAPA, change control, and batch record review Working knowledge of document control/eDMS systems Experience supporting regulatory inspections and audits Strong attention to detail, communication skills, and ability to work cross-functionally #MPG1 Masis Staffing is committed to providing a workplace free of discrimination, harassment, and retaliation. We are an equal opportunity employer. Applicants, employees, and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation or transgender status), national origin, aids (40 or older), veteran status, disability and genetic information (including family medical history).