QA Specialist II — GMP & Quality Improvement

4142 Evonik Corporation_4142; Birmingham (AL); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Hybrid work environment

Job summary

Evonik Corporation in Birmingham, AL is seeking a Quality Assurance professional to join our manufacturing QA team. You will perform QA activities across campaigns, review documentation, and ensure cGMP compliance to support PDS products and services.

Ideal candidates have a STEM degree, 2–5 years in pharma/medical device manufacturing with QA experience, strong analytical skills, and proficiency with Microsoft Office.

Qualifications

• Bachelor's degree preferred; equivalent relevant experience may be substituted.
• 2-5 years in pharmaceutical/medical device manufacturing with at least 1 year in QA.
• Knowledge of FDA cGMP or QSR, with validation experience.
• Strong analytical and problem-solving skills, including statistics and quality investigations.
• Proficient in Microsoft Office with attention to detail and communication.

Responsibilities

• Perform room clearance activities before and during campaigns to ensure cGMP compliance.
• Review manufacturing documentation and final disposition of raw materials, fill/finish components, and batch records.
• Review room cleaning logs and supporting documentation for GMP compliance.
• Review analytical data for site utilities (WFI, clean steam, nitrogen, etc.) for compliance.
• 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, PDS Services, and MDS operations.
• Provide on-call quality support to address manufacturing issues and maintain production continuity.
• Lead product quality and quality system improvement initiatives using data-driven analysis.
• Analyze quality metrics, identify improvement opportunities, and support continuous improvement projects.

Skills

Quality Assurance

cGMP knowledge

Analytical skills

Problem solving

Microsoft Office

Education

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

Job description

Evonik Corporation in Birmingham, AL is seeking a Quality Assurance professional to join our manufacturing QA team. You will perform QA activities across campaigns, review documentation, and ensure cGMP compliance to support PDS products and services.

Ideal candidates have a STEM degree, 2–5 years in pharma/medical device manufacturing with QA experience, strong analytical skills, and proficiency with Microsoft Office.