Senior Quality Assurance Engineer

Vector Talent; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Vector Talent is seeking a QA Senior Engineer to lead inspection, labeling and packaging quality systems for a global CDMO focused on parenteral injectable drugs.

The role involves supervising finished product inspection, labeling, packaging and serialization activities, ensuring compliance with FDA/EMA and related guidelines, and partnering with Manufacturing, Technical Services and QA teams to drive continuous improvement.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline or 10+ years in lieu of a degree.
• Minimum 5 years in pharmaceutical/biopharmaceutical QA with finished product inspection and packaging systems.
• 3+ years in GMP-regulated parenteral/sterile injectable environments.
• Knowledge of FDA (21 CFR Parts 210, 211), EU GMP Annex 1, ICH, USP <790> / <1790> guidance, and DSCSA.
• Experience with visual inspection methods and ISR defect classification.

Responsibilities

• Provide quality oversight for finished product visual inspection of vials, syringes and cartridges.
• Own quality systems for labelling, packaging and serialization ensuring regulatory compliance.
• Author and approve SOPs, work instructions, batch records, specifications.
• Lead deviation investigations, CAPA and root cause analyses.
• Collaborate to develop inspection parameters, AQL criteria and defect libraries.
• Maintain audit readiness for FDA/EMA/client audits.
• Oversee validation of inspection equipment and labeling systems.
• Review change controls, risk assessments and validation reports.
• Support QA floor escalations related to inspection activities.
• Stay updated on evolving regulatory expectations for parenteral products.

Skills

QA Oversight

GMP Knowledge

Serialization

Inspection

Labeling

CAPA

Audits

Documentation

Root Cause

Education

BS in Science

Tools

MS Office

Job description

QA Senior Engineer, Inspection, Labelling and Packaging

This is a unique opportunity to join the Quality Assurance team of a global CDMO specialising in parenteral injectable drug products, in a highly visible role that directly supports the delivery of safe, effective products to patients worldwide. Reporting to the QA Director of Quality Systems, you will be part of a collaborative, fast-paced environment where your expertise in inspection, labelling, packaging and serialisation quality systems will shape the future of the organisation's CDMO operations.

The QA Senior Engineer of Inspection, Labelling and Packaging is responsible for the oversight and continuous improvement of quality systems governing finished product inspection of aseptically filled vials, syringes and cartridges, as well as labelling, packaging and serialisation operations. This role ensures that all associated quality systems are designed, implemented and maintained in a state of regulatory compliance with FDA, EMA and other applicable regulatory requirements. The QA Senior Engineer serves as a subject matter expert (SME) and key quality partner to Manufacturing, Technical Services, Engineering and Supply Chain teams, driving operational excellence and inspection readiness across all inspection, labelling and packaging activities.

Essential Job Functions:

• Provide quality oversight and SME support for finished product visual inspection operations, including manual, semi-automated and automated inspection of filled vials, syringes and cartridges
• Own and manage quality systems related to labelling, packaging and serialisation, ensuring compliance with FDA and EMA regulations, USP/ISO/ICH/PDA/ISPE and other non-governmental guidance documents, and applicable serialisation regulations (e.g. DSCSA)
• Author, review and approve SOPs, work instructions, batch record sections and specifications related to inspection, labelling, packaging and serialisation processes
• Lead or support deviation investigations, root cause analyses and CAPA activities related to inspection defects, labelling errors, packaging failures and serialisation events
• Collaborate with Manufacturing, Engineering and Technical Services to develop and qualify inspection parameters, AQL criteria and defect libraries for new and existing products
• Ensure inspection, labelling and packaging quality systems maintain audit and inspection readiness for FDA, EMA and client audits
• Oversee process validation activities for inspection equipment, labelling systems, packaging lines and serialisation/aggregation systems
• Review and approve change controls, risk assessments and validation protocols/reports impacting inspection, labelling and packaging operations
• Support QA floor oversight as an SME for escalations during inspection, labelling and packaging operations
• Stay current with evolving regulatory expectations and industry best practice for parenteral product inspection, labelling, packaging and serialisation

Special Job Requirements:

• Bachelor's degree in a scientific, engineering or technical discipline (e.g. Biology, Chemistry, Pharmaceutical Sciences, Engineering) required, or 10+ years' experience in a Quality and/or Engineering role with similar responsibilities in lieu of a degree
• Minimum of 5 years' experience in pharmaceutical or biopharmaceutical Quality Assurance, with direct experience in developing and maintaining site or corporate level quality systems for finished product inspection, labelling, packaging and serialisation operations
• Minimum of 3 years' experience in a GMP-regulated parenteral/sterile injectable manufacturing environment
• Demonstrated knowledge of FDA regulations (21 CFR Parts 210, 211), EU GMP Annex 1, ICH guidelines, inspection guidance (USP <790> and <1790>), PDA Technical Reports, and applicable serialisation regulations (DSCSA, EU FMD)
• Experience with visual inspection methods (manual and automated), AQL sampling plans and defect classification systems for injectable drug products
• Strong understanding of quality system elements including deviations, CAPAs, change controls, risk assessments and document management within a QMS
• Experience supporting deviation investigations and CAPA lifecycle management, including root cause analysis, effectiveness checks and timely closure in compliance with site quality system procedures
• Experience supporting client audits and regulatory inspections (e.g. FDA, EMA or other health authority), including preparation of audit-ready documentation, back-room support and response to observations

Additional Preferences:

• Experience in a CDMO or contract manufacturing environment, supporting multiple client programmes simultaneously
• Familiarity with automated inspection technologies, high-speed labelling and packaging, and serialisation/track-and-trace platforms
• Experience with a process validation lifecycle approach, including Stage 1, 2 and 3 activities for inspection, labelling and packaging equipment
• ASQ Certified Quality Engineer (CQE) or similar professional certification

About the Organisation

Our client has built a world-class CDMO for parenteral injectable drugs. Their culture and priorities are focused on building long-term value for customers, with a commitment to a service-culture mindset, technical excellence and a collaborative, team-centred approach to doing business.

This role is based at the client's US facility. Please note that applicants must be authorised to work in the United States on a full-time basis, as visa sponsorship is not available for this role.