QA Specialist II — GMP Compliance & Continuous Improvement

Evonik; Birmingham; Hybrid; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Flexible working

Hybrid work model

Job summary

Evonik Corporation in the United Kingdom seeks a quality assurance professional to support production campaigns for PDS products and services. The role focuses on ensuring cGMP compliance, reviewing batch records, and providing on-the-floor QA support across multiple manufacturing operations.

The ideal candidate has a STEM degree and 2–5 years’ experience in pharmaceutical manufacturing, with strong analytical skills and familiarity with GMP and QSR requirements.

Qualifications

• Strong analytical and problem-solving abilities with attention to detail.
• Experience applying statistics and quality investigations in manufacturing.
• Excellent written and verbal communication and collaboration skills.

Responsibilities

• Perform room clearance activities before and during campaigns to ensure cGMP compliance.
• Review manufacturing documentation and disposition of materials and batch records.
• Review room cleaning logs and documentation for GMP compliance.
• Review data for site utilities and critical systems to support quality.
• Assess environmental monitoring data to ensure cleanroom and product quality.
• Review and approve change control documentation per quality system.
• Provide on-the-floor QA support during campaigns for PDS Products, PDS Services, and MDS operations.
• Provide on-call quality support to address manufacturing issues and maintain production continuity.
• Lead quality system improvement initiatives using data-driven analysis.
• Analyze quality metrics, identify improvement opportunities, and support CI projects.

Skills

Analytical skills

Problem solving

Attention to detail

Communication skills

Education

Bachelor's degree in Chemistry, Biology, Engineering, or STEM

Tools

Microsoft Excel

Job description

Evonik Corporation in the United Kingdom seeks a quality assurance professional to support production campaigns for PDS products and services. The role focuses on ensuring cGMP compliance, reviewing batch records, and providing on-the-floor QA support across multiple manufacturing operations.

The ideal candidate has a STEM degree and 2–5 years’ experience in pharmaceutical manufacturing, with strong analytical skills and familiarity with GMP and QSR requirements.