The role of the Quality Systems Analyst II is to facilitate the compliant and timely use of the Quality Management System(QMS) by Operations, Quality Control, and Quality Assurance through review of QMS record entries for accuracy against primary sources and procedural requirements. The individual must be technically knowledgeable with respect to quality systems, regulatory standards, material flows, and general production and Quality Control principles in the Active Pharmaceutical Ingredient Manufacturing sector. The individual is responsible for supporting the administration of Quality Systems that will affect the long-term quality and manufacturing strategies within the organization. Expected to work collaboratively with Quality Specialists and Management, as well as independently, when appropriate. Works under general supervision.
This position is not remote.
Duties and Responsibilities
Actively promote adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and compliance standards.
Timely review of electronic Quality Management System (QMS) record entries for accuracy against primary documents or sources, procedural compliance, and timeline adherance
Direct communication of required corrections back to QMS Originator in a timely manner and to confirm any required corrections have been appropriately completed.
Periodic reporting and communication of metrics to department stakeholders and Quality Management.
Notify appropriate Quality staff if an issue is observed that may require appropriate documentation and/or investigation and to work with the appropriate quality or production staff to resolve the issue.
All responsibilities are to be carried out in accordance with approved AFC procedures and the requirements of CGMP.
May be involved in the administration of Training materials, as appropriate.
May be involved in the issuance, review, release, and/or reconciliation and archival of production records and labels.
May contribute to continuous improvement initiatives for Quality Systems.
May be involved in presenting Quality System Metric performance, as appropriate
EDUCATION AND EXPERIENCE
An Associate's degree is required for this position.
A Bachelor's degree is preferred for this position.
6-9 years of relevant experience with an Associate's degree.
3-5 years of GMP quality experience with Bachelor's degree.
COMPETENCIES/SKILLS
Strong attention to detail.
Ability to work in a fast pace, team-oriented environment.
Able to work independently, when appropriate.
Able to act with a sense of urgency, while maintaining accuracy and data integrity.
General computer skills, working knowledge of Microsoft Office applications.
Hands on experience in electronic systems, for instance: Documentation Management platforms, Inventory Management Systems and electronic Quality Management Systems (eQMS).
Experience working in primary Quality Management Systems such as Deviations, OOS Investigations, Change Controls, Corrective and Preventive Actions, training systems, etc.
Have a working knowledge of CGMP.
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time
