QMS Process Engineer

Bachem

Quality Management Systems Process Engineer supporting electronic QMS migration project for Bachem. Responsible for quality systems improvement and collaboration with global QA teams.

Posted 6/13/2026full-timeSan Diego • California • 🇺🇸 United StatesMid-LevelSenior💰 $82,969 - $114,083 per yearWebsite

About the role

Key responsibilities & impact

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
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.

Requirements

What you’ll need

Bachelor's Degree in scientific or technical discipline (chemistry, biotechnology, engineering, life sciences)
5+ years' experience in Quality Assurance with a cGMP Manufacturing organization
2+ years' project management experience (preferred)
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

Benefits

Comp & perks

comprehensive Medical/Dental/Vision coverage
annual performance bonus
401(k) plan with employer contribution
paid vacation, personal and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System (QMS)GMP documentationProcess mappingQuality system metricsProject managementAudit supportcGMP complianceProblem resolutionContinuous improvement

Soft Skills

CollaborationOrganizational skillsCommunicationProblem-solvingAdaptability