Senior QA Specialist, Label Control

Are you passionate about ensuring that every label on every life-saving injectable product is accurate, compliant, and traceable? INCOG BioPharma’s QA Label Control team is at the heart of our labeling operations, serving as the quality gatekeepers for one of the most critical steps in pharmaceutical manufacturing. This is a hands-on, high-visibility role where your expertise directly protects patients and supports our clients’ success. You will join a collaborative, fast-paced team that values precision, accountability, and continuous improvement.

The Senior QA Specialist, Label Control is responsible for providing QA oversight of all labeling activities, including label issuance, reconciliation, and incoming pre-printed material release for label and packaging operations. This position leads investigations into label count discrepancies, authors and revises SOPs, and related GMP documents, and serves as a subject matter expert during client and regulatory audits. Reporting to the Supervisor, QA Label Control, this role is integral to maintaining compliance with FDA, EMA, and industry best practices across all labeling operations.

Essential Job Functions:

•             Provide QA oversight of label control activities including label issuance, accountability, storage, and destruction in accordance with cGMP requirements and approved SOPs

•             Perform and oversee label reconciliation for each batch, ensuring accurate counts and documentation prior to line clearance and batch record closure

•             Lead investigations into label count discrepancies, including root cause analysis, impact assessments, and implementation of corrective actions

•             Review and release incoming pre-printed labeling materials (e.g., cartons, vial labels, syringe labels, package inserts) against approved specifications and artwork prior to use in label/pack operations

•             Author, review, and revise SOPs, Work Instructions, and other GMP-controlled documents related to labeling operations

•             Serve as a QA subject matter expert (SME) on the production floor for real-time labeling questions, escalations, and decision-making

•             Support and participate in client audits, FDA inspections, EMA inspections, and other regulatory agency visits as a label control SME

•             Ensure labeling operations comply with applicable regulations including 21 CFR Parts 211 and 610, EU GMP Annex 13, and applicable DSCSA/serialization requirements

•             Collaborate with Manufacturing, Supply Chain, and Project Management to coordinate label inventory, issuance schedules, and packaging campaign readiness

•             Identify and implement continuous improvement opportunities within the label control process to enhance compliance, efficiency, and error prevention

•             Support deviation and CAPA processes related to labeling events, including authoring investigation summaries and effectiveness checks

•             Maintain label control logs, databases, and tracking systems to ensure complete traceability of all labeling materials throughout their lifecycle

Special Job Requirements:

•             Bachelor’s degree in a science, engineering, or related discipline is preferred but not required; equivalent combination of education and relevant experience will be considered

•             Minimum 6 years of experience in a QA or label control role within a GMP-regulated pharmaceutical, biologic, or CDMO environment

•             Minimum 4 years of direct experience with label issuance, reconciliation, and investigation of label count discrepancies

•             Demonstrated experience with incoming inspection and release of pre-printed labeling materials for label/packaging operations

•             Working knowledge of FDA regulations (21 CFR Parts 211, 610), EU GMP requirements, and EMA expectations related to labeling

•             Experience supporting or participating in FDA and/or EMA regulatory inspections and client audits

•             Proficiency in authoring and reviewing Batch Records, SOPs, and other GMP-controlled documents

•             Strong investigative and technical writing skills with the ability to perform root cause analysis and document findings clearly

•             This position reports to the Supervisor, QA Label Control

Additional Preferences:

•             Experience with incoming quality release of pre-printed materials (e.g., cartons, vial labels, syringe labels, package inserts)

•             Experience with serialization and DSCSA compliance requirements

•             Familiarity with sterile injectable drug product manufacturing, including aseptic fill-finish operations

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