We have an opportunity for a Senior Specialist, Quality Systems to join our team. In this role, you will support Quality Systems, including investigation and deviation management, CAPA tracking, and change control. You will compile, trend, and report key quality metrics for management and other quality system functions as needed. This position ensures compliance with regulatory standards and drives quality improvements for GMP manufacturing of biological products.

Shift: Monday - Friday, 8am-430pm
Location: Harmans, MD - BWI
100% Onsite

• Administer and support CAPA, deviation, investigation, and change control processes, ensuring timely completion, effectiveness verification, and regulatory compliance.
• Author, review, and maintain quality records including deviations, investigations, CAPAs, change controls, and GMP documentation such as SOPs.
• Track, trend, and analyze Quality System metrics, providing routine reports to management on risks, performance, and improvement opportunities.
• Conduct CAPA and change effectiveness evaluations using quantitative and qualitative data to verify sustainable outcomes.
• Maintain Quality System tracking tools and reporting mechanisms to ensure organizational visibility and accountability.
• Monitor quality systems, procedures, and compliance activities, identifying opportunities to improve regulatory adherence, efficiency, and overall quality performance.
• Support compliance remediation efforts, quality improvement initiatives, and cross-functional projects as a Quality Assurance representative.
• Develop and deliver Quality Systems training, manage user access, and promote workforce compliance with quality requirements.
• Coordinate and support internal and external audits, including audit preparation, client interactions, observation responses, and follow-up activities.
• Partner with cross-functional teams to enhance quality processes, improve system performance, and maintain ongoing professional training and operational readiness.
• Other duties as assigned.

• Master’s degree in Scientific, Engineering, Biotech, or related field with 2–4 years of experience in the biologic, pharmaceutical, or medical device industry performing hands-on work in Quality Assurance.
• OR Bachelor’s degree in Scientific, Engineering, Biotech, or related field with 4–6 years of experience in the biologic, pharmaceutical, or medical device industry performing hands-on work in Quality Assurance.

• Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 or Quality System Regulations (QSR) per 21 CFR Part 820.
• Proficiency in Microsoft applications including Excel, PowerPoint, Access, Teams, and SharePoint.
• Knowledge of biological regulations (21 CFR Part 600s) or EU GPs is a plus.
• Experience with electronic systems, including developing and producing reports.
• Experience with data analytics and related concepts.
• Ability to quickly learn and navigate new electronic systems.
• Capable of working in a team setting and independently with minimal supervision.
• Ability to work in a fast-paced environment supporting QA/QC departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product.
• Creative individual with strong troubleshooting skills.
• Ability to deliver results in a fast-paced environment to meet client deadlines.

The anticipated salary range for this position in MD is $105,000 – $120,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

personal initiative. dynamic pace. meaningful work.

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