QA Specialist II

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

What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

Want to know what it’s like to work at Evonik? To Support Increase production on PDS Products and PDS services Job Descrip

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.