QA Specialist II — GMP & Continuous Improvement

Evonik España Y Portugal SA.; Birmingham, Northern (AL, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Evonik Industries in the United States is seeking a Quality Assurance professional to support manufacturing campaigns, review documentation, and ensure cGMP compliance across rooms, materials, and batch records.

You'll review environmental monitoring data, change controls, and provide on-the-floor QA support for PDS Products and Services, with 2–5 years in pharma or medical device manufacturing and a STEM degree. Strong analytical skills and proficiency in MS Office are required.

Qualifications

• Bachelor's degree in STEM; equivalent experience may be substituted.
• 2–5 years in pharmaceutical or medical device manufacturing, incl. 1+ year in QA.
• Knowledge of FDA cGMP and/or QSR; experience with validation activities.
• Strong analytical/problem-solving skills; experience with applied statistics and quality investigations.
• Proficient in MS Office with attention to detail and communication skills.

Responsibilities

• Perform room clearance before and during manufacturing campaigns to ensure cGMP compliance.
• Review manufacturing documentation and finalize disposition of raw materials, components, and batch records.
• Review room cleaning logs and supporting GMP documentation.
• Review analytical data supporting site utilities and critical systems.
• Review environmental monitoring data to ensure cleanroom compliance and product quality.
• Review and approve change control documentation per quality system requirements.
• Provide on-the-floor QA support during campaigns for PDS products/services and MDS operations.
• Provide on-call QA support to address manufacturing issues and maintain production continuity.
• Lead product quality and quality system improvement initiatives using data-driven analysis.
• Analyze quality metrics and support continuous improvement projects.

Skills

Analytical thinking

Problem-solving

Quality investigations

Statistics

MS Office

Education

Bachelor's degree in STEM

Tools

Excel

Access

Job description

Evonik Industries in the United States is seeking a Quality Assurance professional to support manufacturing campaigns, review documentation, and ensure cGMP compliance across rooms, materials, and batch records.

You'll review environmental monitoring data, change controls, and provide on-the-floor QA support for PDS Products and Services, with 2–5 years in pharma or medical device manufacturing and a STEM degree. Strong analytical skills and proficiency in MS Office are required.