Associate Quality Management Systems Specialist
About The Position
If your idea of a great day includes keeping systems organized, records accurate, and quality standards on point, this could be the role for you. If you�ve got a sharp eye for detail and a knack for keeping things on track, this QMS role is a great way to make quality count. Join a team where your love of order, process, and precision helps keep quality running smoothly behind the scenes. Who is Meissner? The goal at Meissner is to be more than simply good; it is to be extraordinary. Extraordinary performance comes from extraordinary people. Meissner as a group is passionate about helping our clients manufacture lifesaving and life enhancing drugs, therapies, and vaccines. We develop, manufacture, supply and service advanced microfiltration products and single-use systems worldwide. We know that when you are passionate about what you do, it�s more than just a job. Meissner is focused on the development of the whole individual, and we have programs and tools in place to help us stay at our best mentally and physically. In alignment with our commitment to support the growth and development of the whole individual, Meissner has inaugurated a Learning and Development department to solely focus on cultivating our team. When you grow, we grow. How you will make an impact: The Associate Quality Management Systems (QMS) Specialist plays a key role in maintaining and improving the Quality Management System to ensure compliance with cGMP regulations and client requirements. This position provides Quality subject matter expertise across document control, CAPA, deviations, and audit readiness, partnering cross-functionally with Commercial and Technical Operations teams. The role is responsible for supporting QMS performance through metrics tracking, system administration, and continuous improvement efforts that enable the consistent delivery of safe and effective pharmaceutical products. Collaborate as a solution-oriented team member to work alongside the Commercial and Technical operations teams, delivering QA objectives to support business growth. Track and report metrics and key performance indicators for the Quality Management System. Monitor and follow-up on open actions related to Corrective and Preventative Actions (CAPA), Out of Specification (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 (eDMS), including user access, training, workflows, and maintenance. Ensure documentation compliance with applicable regulations (cGMP) and internal and Quality procedures. Review routine testing, monitoring, and log documentation for compliance. Track document lifecycle milestones and completion. This is an on-site role based out of our headquarters in Camarillo, CA.
Requirements
- 2+ years of experience in a Quality Assurance role within the pharmaceutical or biotechnology industry.
- Working knowledge of cGMP regulations and quality systems, including CAPA, deviations, OOS investigations, and document control.
- 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.
Nice To Haves
- Bachelor�s degree in a scientific, engineering, or related discipline preferred.
- Experience with electronic Quality Management Systems (eQMS) or document management systems is preferred.
Responsibilities
- Track and report metrics and key performance indicators for the Quality Management System.
- Monitor and follow-up on open actions related to Corrective and Preventative Actions (CAPA), Out of Specification (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 (eDMS), including user access, training, workflows, and maintenance.
- Ensure documentation compliance with applicable regulations (cGMP) and internal and Quality procedures.
- Review routine testing, monitoring, and log documentation for compliance.
- Track document lifecycle milestones and completion.
Benefits
- Full Medical, Dental and Vision coverage with HSA Employer Contributions for eligible plans
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
