Senior QA Specialist, Label Control

INCOG BioPharma Services•Fishers, IN

1d•Onsite

About The Position

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.

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

Nice To Haves

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
Experience with electronic QMS platforms (e.g., TrackWise, Veeva, MasterControl) and document management systems
Prior experience at a CDMO or contract manufacturing environment supporting multiple clients and product configurations
Knowledge of label control best practices across multiple global regulatory frameworks

Responsibilities

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