Quality Oversight Sr. Specialist

acino; Goodyear (AZ); On-site; USD 70,000 - 90,000; Full time

Job summary

acino in Goodyear, Arizona is seeking a Quality Assurance professional to ensure compliance with GMP and internal quality standards.

The role involves conducting routine GMP walk-throughs, managing quality-related events, and supporting training initiatives. Candidates should possess a Bachelor’s degree and at least 5 years of experience in a regulated manufacturing environment with strong knowledge of GMP, GDP, and regulatory requirements.

Qualifications

• 5+ years of experience in Quality Assurance in pharmaceutical environment.
• Strong knowledge of regulatory requirements.
• Experience in deviation management and investigations.

Responsibilities

• Conduct GMP walk-throughs to identify compliance gaps.
• Participate in real-time investigations of deviations.
• Support training activities for compliance.

Skills

GMP knowledge

GDP understanding

Deviation management

CAPA process

QMS processes

Data integrity principles

Quality risk management

Education

Bachelor’s degree in pharmacy or related field

Job description

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

This role will be responsible for supporting quality oversight activities to ensure compliance with GMP, regulatory requirements, and internal quality standards across manufacturing, facilities, utilities, and warehouse operations. The role involves conducting routine GMP walk-throughs and Gemba activities, contributing to real-time investigations, and supporting the effective management of deviations, non-conformances, and CAPAs.

Acts as a key contributor to maintaining and improving the Quality Management System (QMS) through participation in gap analysis, SOP review and updates, and promoting data integrity and quality culture initiatives. Provides timely quality impact assessments and supports root cause analysis to ensure issues are appropriately investigated and addressed.

Additionally, the role supports training effectiveness, mentors junior team members on GMP principles and Good Documentation Practices and follows up on implementation and tracking of quality actions to ensure continuous compliance and operational excellence.

Key Responsibilities

• Conduct routine GMP walk-throughs across manufacturing, warehouse, facilities, and utilities to identify compliance gaps and support adherence to regulatory and internal standards
• Perform regular Gemba activities in GxP areas to ensure operations are executed in line with GMP and Good Documentation Practices (GDP)
• Support quality oversight by monitoring departmental activities and highlighting compliance risks in alignment with company policies, GMP, EDA, and ISO requirements
• Participate in real-time investigations of deviations and non-conformances to ensure proper classification, thorough investigation, and timely resolution
• Contribute to root cause analysis (RCA) and support the identification of effective corrective and preventive actions (CAPAs)
• Review CAPA responses, follow up on implementation, and support tracking to ensure effectiveness and closure within defined timelines
• Provide timely quality impact assessments for deviations and issues with potential impact on product quality
• Support trending analysis of deviations and non-conformances to identify recurring issues and improvement opportunities
• Participate in investigations related to manufacturing, facilities, utilities, and environmental monitoring, and support preparation and review of investigation reports
• Contribute to the effectiveness of the Quality Management System (QMS) by participating in gap analyses and supporting continuous improvement initiatives
• Review and update SOPs and support the development of QA procedures in alignment with regulatory expectations
• Promote data integrity and quality culture initiatives within the organization
• Demonstrate and advocate Good Documentation Practices (GDP) across all functions
• Support training activities by ensuring compliance with training requirements and contributing to the effectiveness of learning programs for shift personnel
• Provide guidance, coaching, and knowledge sharing to colleagues on GMP principles and quality best practices
• Support the management of quality-related events within Quality Operations, ensuring appropriate documentation, follow-up, and closure

Qualifications & Experience

• Bachelor’s degree in pharmacy, Science, or a related field
• 5+ years of experience in Quality Assurance within a pharmaceutical or regulated manufacturing environment
• Strong knowledge of GMP, GDP, and regulatory requirements (e.g., EDA, ISO standards)
• Experience in deviation management, investigations, CAPA, and QMS processes
• Familiarity with manufacturing, utilities, and facility operations in a GxP environment
• Experience in SOP review, documentation, and audit readiness activities
• Good understanding of data integrity and quality risk management principles

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!