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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 with cGMP regulations, with a strong focus on CAPA, deviations, and document control. Proven ability to track metrics and support audit readiness while collaborating effectively across teams.
Highest-signal resume keywords
Quality Management Systems (QMS)CGMP RegulationsCAPA ManagementDocument ControlElectronic Quality Management Systems (eQMS)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceMetrics TrackingDocument ManagementGMP Documentation ReviewAudit Preparation
Soft Skills
Attention to DetailEffective CommunicationTeam CollaborationIndependent WorkPriority Management
Tools & Technologies
Electronic Document Management SystemQuality Management Software
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryRegulated EnvironmentOOS InvestigationsQuality Procedures
About the role
Key responsibilities & impact- Maintain and improve the Quality Management System to ensure compliance with cGMP regulations and client requirements
- Provide Quality subject matter expertise across document control, CAPA, deviations, and audit readiness
- Partner cross-functionally with Commercial and Technical Operations teams
- Support QMS performance through metrics tracking, system administration, and continuous improvement efforts
- Collaborate with Commercial and Technical Operations teams to deliver QA objectives supporting business growth
- Track and report metrics and key performance indicators for the Quality Management System
- Monitor and follow up on open actions related to CAPA, OOS reports, and Deviations
- Assist with preparations for internal and external audits, including documentation readiness, traceability, and response to findings
- Oversee document control processes, including creation, revision, distribution, and archival of SOPs, work instructions, and quality records
- Administer the electronic document management system, including user access, training, workflows, and maintenance
- Ensure documentation compliance with applicable cGMP regulations and internal Quality procedures
- Review routine testing, monitoring, and log documentation for compliance
- Track document lifecycle milestones and completion
Requirements
What you’ll need- 2+ years of experience in a Quality Assurance role within the pharmaceutical or biotechnology industry
- Relevant internship or co-op experience considered
- Bachelor’s degree in a scientific, engineering, or related discipline preferred
- Working knowledge of cGMP regulations and quality systems, including CAPA, deviations, OOS investigations, and document control
- Experience with electronic Quality Management Systems (eQMS) or document management systems preferred
- Strong attention to detail with the ability to review and assess GMP documentation for accuracy and compliance
- Ability to manage multiple priorities in a fast-paced, regulated environment
- Effective written and verbal communication skills, with experience interacting cross-functionally and with external clients
- Demonstrated ability to work both independently and collaboratively within a team environment
Benefits
Comp & perks- Full Medical, Dental and Vision coverage with HSA Employer Contributions for eligible plans
- Additional Perks: HQ Onsite Full Gym
- Ultramodern Coffee Bars
- Free EV Charging Stations
- Employee Discounts
- 401k
- Profit Sharing
- 401k Advisory Services
- Company Sponsored Life Insurance
- Employee Assistance Program
- Paid Time Off
- Paid Holidays
- Anniversary Holiday
- Learning and Development programs and tools
- Equal Opportunity Employer
