QA Specialist, GMP & Continuous Improvement

Evonik Oxeno; Birmingham (AL); On-site; USD 65,000 - 90,000; Full time

Job summary

Evonik is hiring a Quality Assurance Specialist in Birmingham, AL. The role provides quality and technical support to the production team, overseeing manufacturing rooms and laboratories by reviewing data and QA documentation to ensure compliance with cGMP and QSR.

Responsibilities include reviewing batch records, change controls, room cleaning logs, and site utilities data, with on-the-floor QA support during campaigns and on-call quality coverage to maintain production continuity.

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field preferred; equivalent relevant experience may be substituted.
• 2–5 years of experience in pharmaceutical or medical device manufacturing, including at least 1 year in a Quality Assurance role.
• Working knowledge of FDA cGMP and/or Quality System Regulations (QSR), with experience supporting validation activities, including process validation.
• Strong technical, analytical, and problem-solving skills, including experience with applied statistics and quality investigations.
• Proficient in Microsoft Office (Word, Excel, Access) with excellent attention to detail, organizational, communication, and interpersonal skills.

Responsibilities

• Perform room clearance activities before and during manufacturing campaigns to ensure cGMP compliance.
• Review manufacturing documentation and perform final disposition of raw materials, fill/finish components, and batch records.
• Review room cleaning logs and supporting documentation for GMP compliance.
• Review analytical data supporting site utilities, including WFI, clean steam, nitrogen, and other critical systems.
• Review environmental monitoring data to ensure cleanroom compliance and product quality.
• Review and approve change control documentation in accordance with quality system requirements.
• Provide on-the-floor QA support during manufacturing 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 while assisting with additional business-critical activities as needed.

Skills

2–5 years experience

FDA cGMP / QSR knowledge

Analytical & problem-solving

MS Office proficiency

Education

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

Tools

Microsoft Office

Job description

Evonik is hiring a Quality Assurance Specialist in Birmingham, AL. The role provides quality and technical support to the production team, overseeing manufacturing rooms and laboratories by reviewing data and QA documentation to ensure compliance with cGMP and QSR.

Responsibilities include reviewing batch records, change controls, room cleaning logs, and site utilities data, with on-the-floor QA support during campaigns and on-call quality coverage to maintain production continuity.