QMS Process Engineer

Bachem AG•Vista, CA

9d•$82,969 - $141,768•Onsite

About The Position

The Quality Management Systems (QMS) Process Engineer / Sr. Process Engineer plays a critical role within the Quality Systems and Compliance team. This position is responsible for supporting the ongoing development, maintenance, and oversight of a new electronic QMS, along with transitioning from the existing EQMS, and associated Quality system processes across Bachem's U.S. sites, while also partnering with QA and other stakeholders at European locations. Additionally, the incumbent serves as a subject matter expert in electronic quality systems implementation, including but not limited to Veeva, MasterControl, LIMS, and SAP. This is a fulltime salaried position with full benefits. The role is primarily dedicated to supporting a quality system migration project with an anticipated duration of two years. It is expected the role will transition into the larger quality organization upon completion of the project.

Requirements

Bachelor's Degree in scientific or technical discipline (chemistry, biotechnology, engineering, life sciences)
5+ years' experience in Quality Assurance with a cGMP Manufacturing organization
Excellent written and oral communication skills and experience in writing standard operating procedures (SOP), and process mapping
Experience with supporting/conducting audits and developing quality system metrics
Comprehensive knowledge of electronic software used in quality systems (e.g. Veeva MasterControl, LIMS, SAP etc.)
Ability to manage projects, organize and work in a fast-paced environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work in a team environment and interact well with co-workers, customers, regulatory agency auditors and senior management

Nice To Haves

Master's Degree
2+ years' project management experience
Hands-on experience with electronic system configuration

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 and assessment.
Process mapping, Draft, and review of GMP documentation e.g. SOPs, protocols, reports
Proactively develop, identifying harmonization potential and optimization of global GMP concept and quality practices within the Bachem Quality Assurance organization within the US and across international sites.
Suggest and implement improvements in quality systems, policies, and SOPs taking into account LEAN GMP approaches to optimize and improve existing processes in quality.
Resolve problems with GMP electronic systems and provide guidance on EQMS topics, providing hands-on support for local sites for the effective and lean implementation of these GMP processes and concepts
Collaborate with QA team members and with other departments to implement improved QMS processes, systems quality culture and documentation landscape.
Support GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed.