Senior Quality Systems Specialist

ABCorp

$85K — $110K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years in quality assurance or related fields in regulated environments
  • Proficient in CAPA, document control, and training systems
  • Experience with internal and external audits
  • Strong documentation skills for SOPs and investigation records
  • Knowledge of root cause analysis and corrective action methods
  • Cross-functional collaboration with Operations and Engineering teams
  • Hands-on experience in manufacturing settings

Responsibilities

  • Enhance the Quality Management System with precise documentation and training.
  • Manage the full lifecycle of quality records, ensuring closure and follow-through.
  • Drive problem-solving for effective corrective and preventive actions.
  • Collaborate with operations to bolster process and change control.
  • Review quality documentation for compliance and effectiveness.
  • Assist with audit preparations and follow-up for internal, customer, and third-party audits.
  • Support training initiatives on quality standards and compliance practices.

Benefits

  • Opportunity to influence quality systems in a transforming business.
  • Engagement in a high-impact role with cross-functional visibility.
  • Chance to build structured quality controls and improve organizational coherence.
  • Contribute to the organization’s move from reactive to proactive quality management.
Full Job Description
ABCorp is seeking a Senior Quality Systems Specialist to help strengthen and standardize our quality operating practices during a period of business and process transformation. This role will play a key part in improving the discipline, clarity, and consistency of our quality systems across documentation, investigations, corrective actions, audits, training, and process change.

This is a high-impact specialist role for someone who is strong in quality systems execution and cross-functional follow-through. The position will help ABCorp move from reactive issue handling toward more consistent, scalable process control by building better structure, stronger records, and more effective quality routines.

Key Responsibilities
  • Support and improve the Quality Management System, including procedures, work instructions, records, document control, training support, audit readiness, and controlled quality documentation.
  • Coordinate and drive quality records from initiation through closure, including nonconformances, deviations, investigations, corrective actions, and preventive actions.
  • Improve closure discipline, ownership clarity, and effectiveness of corrective actions through structured problem-solving methods and practical follow-up.
  • Partner with Operations, Engineering, and related functions to strengthen process control, change control, traceability, and standard work.
  • Review and support controlled documentation such as SOPs, work instructions, specifications, inspection plans, validation-related documents, and quality records.
  • Help maintain calibration and measurement-system discipline where applicable.
  • Support internal, customer, and third-party audits through preparation, document retrieval, response support, and follow-up actions.
  • Assist with customer quality investigations and responses by helping ensure facts are clear, records are complete, and corrective actions are credible.
  • Support training efforts related to quality procedures, defect awareness, traceability, material handling, and document compliance.
  • Help develop practical dashboards and reporting for recurring quality issues, CAPA aging, audit findings, scrap/rework themes, and related metrics.
  • Convert recurring issues and transformation needs into clearer procedures, templates, workflows, and quality controls that are easier for the organization to follow.

What Success Looks Like
  • CAPAs, NCRs, and other quality records are opened, investigated, and closed with stronger discipline and less aging.
  • Audit preparation is more organized, findings are reduced, and follow-up actions are completed on time.
  • Procedures, work instructions, and controlled records are clearer and more consistently used.
  • Customer quality responses are better supported by facts, documentation, and more durable corrective actions.
  • The site has better quality visibility, better operating rhythm, and fewer repeat issues caused by process gaps or unclear ownership.

Qualifications
  • 5+ years of experience in quality assurance, quality systems, compliance, or manufacturing quality in a regulated or controlled production environment
  • Experience with CAPA, deviations, nonconformances, investigations, change control, document control, and training systems
  • Experience supporting internal and external audits
  • Strong written documentation skills, including SOPs, work instructions, audit responses, and investigation records
  • Familiarity with root cause analysis and corrective action methods
  • Ability to work cross-functionally with Operations, Engineering, and other teams to drive follow-through
  • Hands-on comfort in a manufacturing environment and ability to connect systems work to floor execution
  • Strong organizational discipline and attention to detail
  • Experience with QMS, ERP, or workflow systems

Nice to Have
  • Experience in printing, converting, card manufacturing, packaging, or another high-mix controlled manufacturing environment
  • Familiarity with ISO 9001, ISO 14298, ISO 13485, or similar quality systems
  • Experience with calibration systems, traceability controls, or product/process release documentation
  • Experience helping standardize records, templates, and site procedures during periods of operational change

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