Quality Systems Analyst II

$68,500 - $91,500/Yr

Ampac Fine Chemicals - Rancho Cordova, CA

Full-time - Mid Level

Onsite - Rancho Cordova, CA

1-10 employees

Chemical Manufacturing

About the position

The Quality Systems Analyst II at AMPAC Fine Chemicals plays a crucial role in ensuring compliance and efficiency within the Quality Management System (QMS). This position involves reviewing QMS record entries for accuracy and adherence to regulatory standards, particularly in the Active Pharmaceutical Ingredient Manufacturing sector. The analyst will collaborate with various teams to support quality systems that impact long-term manufacturing strategies, while also promoting Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

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.
• Notify appropriate Quality staff of issues requiring documentation or investigation and assist in resolution.
• Administer training materials as appropriate.
• Issue, review, release, and reconcile production records and labels as needed.
• 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.