Quality Assurance Analyst

Evonik; Lafayette (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Evonik Corporation in Lafayette, Indiana seeks a QA Compliance professional to ensure daily manufacturing operations meet cGMP and ISO 9001 requirements. The role mentors the Assistant QA representative and supports audits and regulatory readiness.

Ideal candidates hold a BS in chemistry, engineering, or related field with 3–5 years GMP experience, demonstrating change controls, deviation investigations, and validation documentation. Strong communication and 24/7 coverage readiness are essential.

Qualifications

• BS in chemistry, engineering, science, or equivalent experience.
• 3-5 years industrial experience in a GMP environment with good technical understanding of GMP regulations.

Responsibilities

• First point of contact for production issues and compliance questions.
• Provide or approve initial assessments for all quality events.
• Collaborate with Operations, then review and approve minor deviations and change controls.
• Review validation documents.
• Disposition all GMP API and final intermediate batches produced in the production area and support auto-disposition of non-final intermediates.
• Ensure adherence to site cleaning program.
• Approve Master Production Records.
• Review and approve all process start up activities and provide oversight for audit-related activities.
• Contribute to continuous improvement via project teams.

Skills

Communication

Decision making

Teamwork

GMP knowledge

Education

BS in chemistry, engineering, science, or equivalent

Tools

SAP

TrackWise

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.

This position is responsible to ensure that daily manufacturing operations remain compliant with cGMP and ISO 9001 requirements. The person in this role is expected to ensure compliance in the areas that they support through understanding of the compliance requirements of the products produced. The position will provide mentorship to the Assistant QA representative position.

RESPONSIBILITIES

• First point of contact for production issues and compliance questions.
• Provide or approve the initial assessments for all quality events.
• Collaborate with Operations, then review and approve minor deviations and change controls.
• Review validation documents.
• Disposition all GMP API and final intermediate batches produced in the production area and support auto-disposition of non-final intermediates (includes resolution of issues).
• Ensure adherence to site cleaning program.
• Approve Master Production Records.
• Review and approve all process start up activities provide oversight for audit related activities such as equipment use logs, quarterly housekeeping, etc.
• Contribute to continuous improvement via membership on project teams (eg., efficiency projects and implementation of new standards).
• Provide backup room support for customer audits and inspections by regulatory agencies.

REQUIREMENTS

• BS in chemistry, engineering, science, or equivalent experience is preferred.
• 3-5 years industrial experience in a GMP environment with good technical understanding of the GMP regulations and applications is preferred.
• Application of GMPs have been demonstrated with experience in many aspects of the quality systems, such as change controls, deviation investigations, and validation documentation.
• Able to apply compliance standards to daily production situations.
• Good communication skills (written and verbal).
• Computer skills; experience with Microsoft Office programs required, SAP and TrackWise experience is a plus.
• Strong decision making and problem solving skills.
• Must provide 24/7 coverage for areas supported, willing to work nights and weekends as needed.
• Proven ability to work in a team environment.

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.