QA Specialist II

Posted 6 Days Ago
Be an Early Applicant
2 Locations
In-Office
Mid level
3D Printing • Chemical
The Role
Performs quality assurance activities for pharmaceutical manufacturing, including room clearance, batch record and materials disposition, cleaning log review, utility and environmental monitoring data review, change control approval, and on-floor manufacturing support. Leads quality improvement initiatives, analyzes quality metrics, supports investigations and validation activities, and provides on-call quality support to maintain production continuity and cGMP compliance.
Summary Generated by Built In

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.

 

Click on the link below to learn what our employees have to say about Evonik:
https://careers.evonik.com/en/about/meet-the-team/

Meet the Team - Evonik Industries

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.

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 is

Evonik Corporation

Skills Required

  • Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field; equivalent relevant experience may substitute.
  • 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).
  • Experience supporting validation activities, including process validation.
  • Strong technical, analytical, and problem-solving skills, including applied statistics and quality investigations.
  • Proficiency in Microsoft Office, including Word, Excel, and Access.
  • Excellent attention to detail, organizational, communication, and interpersonal skills.

Evonik Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Evonik and has not been reviewed or approved by Evonik.

  • Healthcare Strength The U.S. package consistently includes medical, dental, and vision coverage, supported by HSA/FSA and an Employee Assistance Program. Benefits information highlights robust health coverage alongside base pay.
  • Retirement Support Retirement offerings include a 401(k) and references to legacy pension and retiree medical for eligible groups, indicating depth beyond a basic plan. Company materials and postings emphasize retirement support as part of a comprehensive package.
  • Leave & Time Off Breadth Paid time off, paid holidays, and parental leave are listed across recent U.S. postings. These time‑off programs appear as core elements of the package.

Evonik Insights

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The Company
HQ: Essen
13,812 Employees
Year Founded: 2007

What We Do

Evonik is one of the world’s leading specialty chemicals companies. While we don’t produce electric cars, aircraft, medications or 3D printers, Evonik is part and parcel of these and many other end products. That’s because we contribute the small things that make a big difference. We make electric car batteries perform better, aircraft greener, medications more effective and 3D printers more efficient. In short: We think beyond the bounds of chemistry to make the world a better place. Today and tomorrow. We are an international group with a workforce of over 32,000 people spread across more than one hundred locations. Our daily work is shaped by global concerns, such as sustainability, diversity and digitalization. In all our business decisions, we take the present and future generations into consideration. After all, being ready for tomorrow is our business. Interested in joining our global team? Our wide range of opportunities extends from creative and innovative research through international management all the way to production. Whether you’re studying, starting out in your career or a seasoned professional, come help us make the world a better place. For more information about careers at Evonik, go to: www.careers.evonik.com. #HumanChemistry Find our netiquette on: www.evonik.com/netiquette

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