Evonik · 1 week ago
Sr Quality Assurance Specialist
Birmingham, AL
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expEvonik is a global leader in specialty chemicals, committed to sustainability and innovation. The Sr Quality Assurance Specialist will provide quality and technical support to the production team, overseeing manufacturing processes and ensuring compliance with quality management systems.
ChemicalChemical EngineeringIndustrialIndustrial Engineering
Responsibilities
Represent quality department on development project teams
Review and approve product and process-related documentation
Support the generation and justification of product and materials specifications
Provide support for the development of validation strategies and validation plans
Review/approve protocols and reports
Support Deviation / CAPA investigations
Support interdisciplinary teams for root cause analysis of quality deficits using known of problem-solving tools
Support product quality and System improvements activities
Support collection and analyze data to identify opportunities for quality improvement
Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints
Support to facilitate risk assessment activities such as design and process FMEA
Ensure product risks are identified, and risk mitigation controls are put in place to eliminate product risk to an acceptable level
Provide real time production floor QA oversight
Evaluate manufacturing data for trends and other special causes
Review and disposition manufacturing / packaging batch documentation
Perform room / line clearances as needed
Review and disposition raw materials / components for manufacturing
Support resolution of quality issues in manufacturing
Qualification
Required
Bachelor of Science degree in Chemistry, Biology, or Engineering
Minimum eight years' experience in pharmaceutical or medical device manufacturing, preferred
Minimum five years' experience in a pharmaceutical or medical device Quality Assurance role preferred
Proficient computer skills, Microsoft Word, Excel, Access
High attention to detail, organization, and accuracy
Strong written and verbal communication skills
Good interpersonal skills
Knowledge of FDA's cGMP and/or QSR quality system requirements
Comprehensive technical skills/knowledge
Advanced analytical and problem-solving skills
Experience in Regulatory Agency inspections
Experience in aseptic techniques and manufacturing
Preferred
Applied statistics experience, preferred
Validation experience, including process validation
Benefits
Performance-based remuneration
Occupational health benefits
Hybrid and flexible working environments
Company
Evonik
Evonik goes beyond the boundaries of chemistry with its combination of innovative strength and leading technological expertise.
10001+ employees
H1B Sponsorship
Evonik has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (9)
2023 (16)
2022 (6)
2021 (8)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$4.85BKey Investors
European Investment BankTemasek HoldingsCVC Capital Partners
2025-09-02Post Ipo Debt· $581.65M
2024-03-13Post Ipo Debt· $547.64M
2013-04-25IPO
Leadership Team
Anne Ritter
Global Director, Partnerships and Strategy- Care Solutions
Bernhard Mohr
Managing Director Evonik Venture Capital
Recent News
2025-11-21
Company data provided by crunchbase