Quality Systems Analyst II

Ampac - Rancho Cordova, CA

Full-time

Onsite - Rancho Cordova, CA

Health and Personal Care Retailers

About the position

The Quality Systems Analyst II plays a crucial role in ensuring the compliant and timely use of the Quality Management System (QMS) within the organization. This position involves reviewing QMS record entries for accuracy and compliance with regulatory standards, and supporting the administration of Quality Systems that impact long-term quality and manufacturing strategies. The analyst will work collaboratively with Quality Specialists and Management while also being able to operate independently under general supervision.

Responsibilities

• Promote adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Review electronic Quality Management System (QMS) record entries for accuracy against primary documents and procedural compliance.
• Communicate required corrections to QMS Originators in a timely manner and confirm completion of corrections.
• Report and communicate metrics to department stakeholders and Quality Management periodically.
• Notify appropriate Quality staff of any issues that may require documentation or investigation and assist in resolving them.
• Carry out responsibilities in accordance with approved AFC procedures and CGMP requirements.
• Assist in the administration of training materials as appropriate.
• Participate in the issuance, review, release, reconciliation, and archival of production records and labels.
• Contribute to continuous improvement initiatives for Quality Systems.
• Present Quality System Metric performance as appropriate.

Requirements

• Associate's degree required; Bachelor's degree preferred.
• 6-9 years of relevant experience with an Associate's degree.
• 3-5 years of GMP quality experience with a Bachelor's degree.
• Strong attention to detail.
• Ability to work in a fast-paced, team-oriented environment.
• Ability to work independently when appropriate.
• Ability to act with urgency while maintaining accuracy and data integrity.
• General computer skills and working knowledge of Microsoft Office applications.
• Hands-on experience in electronic systems such as Documentation Management platforms and electronic Quality Management Systems (eQMS).
• Experience with primary Quality Management Systems including Deviations, OOS Investigations, Change Controls, and Corrective and Preventive Actions.

Nice-to-haves

• Working knowledge of CGMP.