Quality Assurance Specialist

Responsibilities

• Perform product lot disposition by reviewing packaging records for completeness, accuracy, and GMP compliance
• Lead investigations, Non-Conformance Material Reports (NCMRs), and customer complaints
• Track and monitor Corrective and Preventive Actions (CAPAs)
• Perform document change control activities and collect quality metrics
• Conduct QC line clearances, in-process checks, and monitor labeling and packaging activities on the production floor
• Support internal, supplier, regulatory, and customer audits
• Perform QC inspection or release of incoming GMP materials according to specifications

Requirements

• High School Diploma and/or 3-5 years of related experience or training
• Basic mathematical and computer skills
• Strong problem-solving and high reasoning abilities
• Ability to interpret various instructions and solve practical problems in non-standardized situations
• Professional proficiency in verbal and written communication

Preferred Qualifications

• 3+ years of experience in Quality Assurance within a cGMP-regulated environment
• Knowledge of Six Sigma or A3 problem-solving methodologies

Benefits

• Competitive salary and eligibility for an annual performance bonus
• Paid time off
• Health insurance coverage, including dental and vision
• Flexible spending account
• 401(k) plan

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.