Senior Specialist, Client QA

Catalent•Harmans, MD

4d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

LIMS, Master Control and Trackwise knowledge preferred.

Responsibilities

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.