Quality Assurance Specialist

Evonik; Birmingham (AL); On-site; USD 70,000 - 90,000; Full time

Job summary

Evonik in Birmingham, AL is seeking a Quality Assurance Specialist to provide QA support to production rooms and laboratories, reviewing manufacturing batch records and supporting analytical data to ensure cGMP compliance.

The role requires a STEM degree and 2–5 years in pharma/medical device manufacturing with QA exposure, plus strong analytical and problem-solving skills. On-the-floor QA during campaigns and change-control reviews are key duties.

Qualifications

• Bachelor's degree in STEM fields or equivalent experience.
• 2–5 years in pharmaceutical or medical device manufacturing with QA exposure.
• Working knowledge of FDA cGMP and QSR; validation experience.
• Strong analytical, technical, and problem-solving skills.

Responsibilities

• Perform room clearance and ensure cGMP compliance during manufacturing campaigns.
• Review batch records, raw materials, and fill/finish components for disposition.
• Verify room cleaning and GMP documentation; review environmental monitoring data.
• Review change controls and support on-the-floor QA during campaigns.
• Provide on-call QA support to maintain production continuity.
• Lead quality-improvement initiatives using data-driven analysis.

Skills

Analytical skills

Problem solving

Data analysis

Education

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

Tools

Microsoft Office

Job description

## Quality Assurance Specialist,Apply: Birmingham, AL: Full time: Posted Today: R52321**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.htmlThis 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.**Your Application**To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at www.evonik.com/en/careers.html.Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.**Your Talent Acquisition Manager:**Kelvin Seals [C]Company isEvonik Corporation