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Quality Assurance
Mentor Technical Group. Lead and coordinate Quality activities associated with the Maintenance System assessment .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) and compliance within pharmaceutical manufacturing, with a strong focus on regulatory requirements, documentation practices, and cross-functional coordination. Proficient in identifying compliance gaps and facilitating effective communication among stakeholders.
Highest-signal resume keywords
Quality Management Systems (QMS)Current Good Manufacturing Practices (cGMP)Change Control ProcessesTechnical Documentation ReviewBilingual: English and Spanish
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ValidationQualificationVerificationRegulatory Impact AssessmentsAuditingAnalytical SkillsProblem-SolvingProject Management
Soft Skills
Communication SkillsPrioritization
Tools & Technologies
MS Office Applications
Industry Keywords
Pharmaceutical ManufacturingComplianceEngineering Change ManagementMaintenance System Assessment
About the role
Key responsibilities & impact- Lead and coordinate Quality activities associated with the Maintenance System assessment
- Assess applicable QMS requirements and compliance controls
- Review maintenance procedures, workflows, and documentation practices
- Evaluate CMMS use and Work Order documentation from a Quality and Compliance perspective
- Assess governance, roles, responsibilities, and escalation processes
- Review Change Management and Engineering Change Management processes
- Evaluate interfaces between Engineering, Manufacturing, Maintenance, Operations, C&Q, Quality, and Materials Management
- Participate in interviews, process walkthroughs, and documentation reviews
- Identify compliance gaps, risks, and improvement opportunities
- Support the development and prioritization of corrective and improvement actions
- Track identified observations and actions through completion
- Provide Quality guidance to project stakeholders
- Support preparation of assessment reports and management presentations
- Coordinate Quality-related assessment activities
- Ensure consistency in the evaluation of compliance requirements
- Facilitate communication between Quality and other functional areas
- Escalate significant compliance risks or concerns
- Support development of practical and sustainable recommendations
- Monitor progress against agreed action plans
Requirements
What you’ll need- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field
- Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing environment
- Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements
- Experience with Change Control processes, regulatory impact assessments, and cross-functional coordination
- Excellent skills in reviewing, auditing, and writing technical documentation
- Ability to manage multiple projects and prioritize tasks effectively
- Strong analytical, problem-solving, and communication skills
- Proficient in MS Office applications (Word, Excel, PowerPoint, etc.)
- Bilingual: fluent in English and Spanish preferred
Benefits
Comp & perks- Equal opportunity employment
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