QA Specialist II

About the role

The QA Specialist II provides on‑floor quality assurance support for pharmaceutical and medical device manufacturing campaigns, ensuring compliance with cGMP and quality system regulations while driving continuous improvement.

Key responsibilities

• Perform room clearance activities before and during campaigns to maintain cGMP compliance.
• Review manufacturing documentation, raw‑material disposition, fill/finish components, and batch records.
• Validate room cleaning logs and related GMP documentation.
• Analyze analytical data for site utilities such as WFI, clean steam, and nitrogen.
• Assess environmental monitoring data to ensure cleanroom compliance and product quality.
• Approve change‑control documentation in line with quality system requirements.
• Provide on‑floor and on‑call QA support for PDS products, services, and MDS operations.
• Lead product‑quality and quality‑system improvement initiatives using data‑driven analysis.
• Analyze quality metrics, identify improvement opportunities, and support continuous‑improvement projects.

Required profile

• Bachelor’s degree in Chemistry, Biology, Engineering or related STEM field (or equivalent experience).
• 2–5 years of experience in pharmaceutical or medical‑device manufacturing, including at least 1 year in a QA role.
• Working knowledge of FDA cGMP and/or Quality System Regulations (QSR) with validation experience.
• Strong analytical and problem‑solving abilities, including applied statistics and quality investigations.
• Proficiency with Microsoft Office (Word, Excel, Access) and excellent attention to detail.

Required skills

• FDA cGMP
• Quality System Regulations (QSR)
• Process validation
• Applied statistics
• Quality investigations
• Microsoft Word
• Microsoft Excel
• Microsoft Access

What we offer

• Performance‑based remuneration
• Occupational health benefits
• Hybrid and flexible working environment (#SmartWork)
• Career development and high‑quality training programs