Senior Specialist, Client QAPosition Summary:- Work Schedule: Monday - Friday, 8am - 5pm.
- 100% on-site
The Senior Specialist, Client QA is responsible for providing QA support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The Senior Specialist, Client QA serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.
The Senior Specialist, Client QA will report to the Manager, Client QA.
The Role- Provide dedicated QA support for client projects and client interactions, serving as the primary QA contact throughout the project lifecycle.
- Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product
- Support clinical and commercial QA activities from process development through non-clinical and commercial production.
- Track and present key quality metrics for client projects, including batch release timelines and deviation trends.
- Collaborate with clients during initial and subsequent manufacturing campaigns to ensure compliance and quality standards.
- Review and approve master batch records during technology transfer for client processes.
- Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs)
- Perform risk assessments and mitigation strategies using tools such as FMEA.
- Maintain and update systems and databases for tracking manufacturing and quality activities.
- Support audits and inspections by regulatory agencies and clients and assist with internal GMP audits.
- Other duties as assigned.
The Candidate- Masters' degree in a Scientific, Engineering or Biotech field with a minimum of 2 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry OR
- Bachelor's degree in a Scientific, Engineering or Biotech field with a minimum of 4 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
- Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
- Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.
- Creative individual with strong analytical, troubleshooting, and decision-making skills to resolve complex issues effectively.
- Ability to quickly learn new and novel manufacturing processes supporting new clients
- Proven ability to work independently and in cross-functional teams, delivering high-quality results in a fast-paced, deadline-driven environment while meeting client and regulatory requirements.
The anticipated salary range for this position in Maryland is $93,000 to $115,000 plus an annual bonus, when eligible. 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.
Why you should Join Catalent- Potential for career growth within an expanding team.
- Defined career path and annual performance review & feedback process.
- Cross-functional exposure to other areas within the organization.
- Medical, Dental, Vision, and 401K are all offered from day one of employment.
- 152 hours of PTO and 8 paid holidays.
- Opportunity to work on Continuous Improvement Processes
