Quality Systems Specialist

Responsibilities

• Write and review SOPs, Work Instructions, BPRs, and Forms
• Manage deviations, non-conformance reports, and corrective action requests
• Follow up on change control actions to ensure timely closure
• Prepare quarterly reports, product quality reviews, and monthly/annual metrics
• Complete complaint investigations and assist with close-out processes
• Perform cGMP internal audits and assist with external audits
• Execute training for quality and other relevant personnel
• Assist with preparation and responses for customer and regulatory audits
• Identify and support opportunities for process and procedure improvements

Requirements

• Bachelor’s, Associate degree, or Diploma in GMP, Regulatory, Compliance, or a similar field
• 1+ years of experience working in a GMP or regulated environment
• Proficient in Microsoft Office products (Excel, PowerPoint, Word, etc.)
• Valid driving license
• Strong problem-solving, troubleshooting, and multitasking skills
• Ability to work collaboratively in a results-driven environment

Preferred Qualifications

• Experience in Lean Manufacturing
• Experience using Lean tools to develop continuous improvements

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 quality and operational excellence, fostering an inclusive culture where talented individuals can grow their careers through intentional learning and purposeful work.