QMS Process Engineer

3w3 weeks ago

Bachem

Vista, US · Full-time · $82,969 – $141,768

About this role

This position plays a critical role within the Quality Systems and Compliance team, supporting the ongoing development, maintenance, and oversight of a new electronic Quality Management System (eQMS). The role also involves transitioning from the existing EQMS and partnering with QA and stakeholders at European locations.

Day-to-day responsibilities include managing QMS system enhancement projects, improving metrics and calculations, and issuing reports to assess the health of the US quality system. The engineer also drafts and reviews GMP documentation such as SOPs, protocols, and reports, and resolves problems with eQMS topics.

The role requires collaboration with QA team members and other departments to implement improved QMS processes and foster a quality culture. The position works in a fast-paced, global environment with both local sites and international partners.

This is a fulltime salaried position dedicated to a quality system migration project with an anticipated duration of two years. Upon completion of the project, the role is expected to transition into the larger quality organization, offering long-term growth.

Requirements

Bachelor's Degree in a scientific or technical discipline (chemistry, biotechnology, engineering, life sciences). Master's Degree preferred.
5+ years of experience in Quality Assurance within a cGMP Manufacturing organization.
2+ years of project management experience preferred.
Excellent written and oral communication skills with experience in writing standard operating procedures (SOP) and process mapping.
Experience with supporting or conducting audits and developing quality system metrics.
Comprehensive knowledge of electronic software used in quality systems (e.g., Veeva, MasterControl, LIMS, SAP).
Ability to manage projects, organize, and work in a fast-paced environment with proactive, solution-focused communication.
Detail-oriented with troubleshooting skills and experience with electronic system configuration preferred.

Responsibilities

Manage QMS system enhancement projects and collaborate locally and globally with the continuous improvement, maintenance, and oversight of the Quality Systems.
Assist with improving metrics/calculations and issuing reports to assess the health of Bachem US quality system including global level reporting.
Process mapping, draft, and review of GMP documentation such as SOPs, protocols, and reports.
Proactively identify harmonization potential and optimization of global GMP concepts and quality practices within the US and across international sites.
Suggest and implement improvements in quality systems, policies, and SOPs using LEAN GMP approaches to optimize existing processes.
Resolve problems with GMP electronic systems and provide guidance on EQMS topics, offering hands-on support for local sites.
Collaborate with QA team members and other departments to implement improved QMS processes and quality culture.
Support GMP audits for internal operations, GMP compliance improvements, and provide GMP compliance guidance to other departments.

Benefits

Full-time salaried position with comprehensive benefits package.
Opportunity for professional growth and transition into the larger quality organization after project completion.