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.
The Quality Assurance (QA) Specialist role offers comprehensive cross-functional support encompassing QA, operations and customer-facing activities through close collaboration with production buildings, Document Services, Quality Analysts, Project Managers and QA leadership. In this position you will provide backup support for the GMP Document Repository by issuing, approving and archiving Batch Production Records (BPRs); managing job aids and eDMS documents; and supporting operational areas through the full lifecycle of production records from issuance through final review and approval, log-book reviews, deviation/change-control approvals and master-record management. You will assist QA Project Management by providing audit support, reviewing and managing quality-system records in platforms such as TrackWise, MasterControl, LMS and eDMS, planning, organizing and tracking project deliverables, and directly engaging with customers via shared-data environments. You will also support QA leadership by collecting background data for audit readiness, tracking deviation history, drafting and tracking CAPAs, compiling metrics and preparing monthly metric presentations. This multifaceted role requires a high degree of independence, guided by mentorship from the QA Representative, Document Services and Project Manager, and supports the overarching commitment to quality and operational excellence.
Responsibilities
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- Document Services Support: Manage GMP Document Repository, issue and archive Batch Production Records (BPRs), and maintain job aids and eDMS documents.
- Quality Event Oversight: Serve as backup QA Representative, assess and approve minor quality events, deviations, and change controls.
- Production Record Management: Approve Master Production Records, review validation documents, and oversee process startup activities.
- Batch Disposition: Disposition GMP API and intermediate batches, including auto-disposition of non-final intermediates under mentorship.
- Audit and Inspection Support: Provide backroom support during audits, oversee equipment logs and housekeeping activities.
- Project Management Assistance: Help QA Project Managers plan, organize, and track deliverables, and maintain quality documentation.
- Training and SOP Development: Assist in creating and editing training manuals, SOPs, and ensure accurate documentation.
- Quality Systems Oversight: Maintain and review records in systems like TrackWise, MasterControl, LMS, SAP, and support CAPA processes
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Requirements
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- A seasoned professional with 5+ years of experience preferred
- Previous QA/QC experience preferred
- Demonstrated ability to work independently and in team setting required.
- Be effective in influencing across functions.
- Computer skills, including Microsoft Office 365; Outlook, Excel, Word, PowerPoint.
- Demonstrated knowledge and experience with cGMP are preferred.
- Previous experience SuccessFactors, MasterControl, Regulus, SharePoint, SAP, TrackWise and/or Concur are preferred.
- Skill in using audio/video communication systems.
- Strong verbal and written communication skills.
- Outstanding communication and interpersonal skills with the ability to work with all levels in the organization, external customers, and co-workers.
- Ability to maintain confidentiality of information with absolute integrity and discretion.
- Self-directed, self-managed, reliable, and capable of success with minimal supervision.
- Ability to influence groups without having direct supervisory responsibility.
- Excellent time management and attention to detail.
- Ability to problem solve and think creatively with innovation in mind.
- Flexibility to handle urgent issues from a large volume of requests.
- Strength in organization / prioritization. Ability to handle multi-task and work well under pressure with aggressive deadlines, including last minute requests.
- Follows company policy and completes all training prior to execution of activity.
- Demonstrated ability to comply with detailed policies and regulations and standard operating procedures
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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 https://careers.evonik.com .
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:
Hannah Snider [C]
Company is
Evonik Corporation