Senior QA Specialist - Label Control

Senior QA Specialist - Label Control

WHO?:

INCOG BioPharma is launching their Label Control team, which will be at the heart of their labeling operations, serving as the quality gatekeepers for one of the most critical steps in pharmaceutical manufacturing. This role will report into the Supervisor of QA Label Control, and is integral in maintaining compliance with FDA, EMA, and industry best practices.

WHAT?:

• 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

YOU:

Ideally, candidates will have a Bachelor’s degree in Science/Engineering/Related discipline as well as the following:

• 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
• (Preferred) Experience with incoming quality release of pre-printed materials (e.g., cartons, vial labels, syringe labels, package inserts)
• (Preferred) Experience with serialization and DSCSA compliance requirements
• (Preferred) Familiarity with sterile injectable drug product manufacturing, including aseptic fill-finish operations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.