Quality Assurance Specialist,

Evonik; Birmingham (AL); On-site; USD 75,000 - 105,000; Full time

Job summary

Evonik is seeking a QA specialist in Birmingham, AL, to provide quality and technical support to production, reviewing batch records, analytical data, and related documents to ensure cGMP compliance. The role involves on-the-floor QA during campaigns and partnering with engineering, manufacturing, and validation teams.

Qualified candidates have a STEM bachelor’s degree and 2–5 years in pharmaceutical or medical device manufacturing, with strong analytical and problem-solving skills and

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field preferred.
• 2–5 years of experience in pharmaceutical/medical device manufacturing.
• Strong technical, analytical, and problem-solving skills; good communication.

Responsibilities

• Perform room clearance activities to ensure cGMP compliance.
• Review manufacturing records and approve final disposition of materials and batch records.
• Review environmental monitoring data to ensure cleanroom quality.
• Review and approve change controls and supporting documentation.
• Provide QA support on the floor during manufacturing campaigns and drive quality improvements.

Skills

Quality Assurance

cGMP

Analytical skills

Problem solving

Education

BSc in Chemistry/Biology/Engineering

Tools

Microsoft Office

Job description

What we offer At Evonik, you're part of a global chemical company working in many sectors that go beyond chemistry. From lipids for tomorrow's medicines, biosurfactants for green detergents, additives for plastics recycling or membranes to help drive forward the energy transition, you'll play an essential part in helping the world's most essential industries succeed. Our success hinges on a diversity of ideas powered by people, not egos. Whether you're a scientist or engineer, new to the team or established, in business, production, or anything in between - we cheer each other on. Because we believe we can do anything. Explore everything. And Be Part of Something Special!

Find out more about the many benefits we offer: https://www.evonik.com/en/careers/why.html

Meet the team and get to know the people behind Evonik: https://www.evonik.com/en/news/meet-the-team.html

This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality management System documentation. This position will be required to review manufacturing batch production records and supporting analytical data, as required. This position may be required to review and approve engineering, manufacturing, and validation documentation, prior to and after execution. All company safety, health and environmental policies, procedures and directives will be adhered to while performing assigned tasks

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.

REQUIREMENTS

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.

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

This is your opportunity to join a thriving global organization that combines cutting-edge science, technology and engineering with world-class business services to create solutions that answer real-world problems. If you join us, we'll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you'll enjoy opportunities to improve and to be respected for your contribution.