Quality Management Systems Consultant (Remote) Job Listing at Kelly Services in Redwood City, CA (Job ID US3547608_BH9771223)

Description

Quality Management Systems Consultant (Remote)
Temp: 3 – 6 months, with potential conversion
Pay: $65 - $85/hour
 
We are seeking an experienced Quality Management Systems Consultant to join our team. This role will serve as the subject matter expert for MasterControl, ensuring the efficient operation, maintenance, and optimization of our electronic document management system (eDMS) and electronic learning management system (eLMS). The consultant will also support broader Quality Operations, including document control, training administration, and quality systems management.
 
Key Responsibilities

• Serve as MasterControl system administrator, managing eDMS and eLMS processes.
• Provide guidance on the effective use of MasterControl to ensure compliance with company policies and industry standards.
• Oversee document control, including document lifecycle management and workflow approvals.
• Administer and manage the training program, including training assignments and records.
• Manage and review quality systems processes, including CAPAs, deviations, change controls, complaints, and investigations.
• Ensure compliance with ICH Guidelines, ISO9001, ISO13485, and phase-appropriate GMP regulations.
• Perform internal and external audits, including supplier qualifications and customer quality audits.
• Work directly with internal and external operational teams to ensure products meet quality standards and regulatory requirements.
• Develop and implement continuous improvement initiatives for internal quality systems and processes.
• Track and report on quality system metrics to support organizational goals.

 
Qualifications

• Bachelor's degree (or equivalent) in Life Science or a related discipline; advanced degree preferred.
• 8+ years of experience in Quality Assurance, supporting manufacturing and quality control in the pharmaceutical or biotech industry.
• Direct experience as a MasterControl Administrator (eDMS and eLMS).
• Strong project management skills, with the ability to manage multiple priorities and meet deadlines.
• Experience in the oversight and approval of quality systems documentation.
• Knowledge of ICH Guidelines, ISO9001, ISO13485, and GMP regulations.
• Strong problem-solving, analytical, and organizational skills.
• Ability to work independently in a remote setting while effectively collaborating with cross-functional teams.
• Excellent communication and training skills to support system users and quality initiatives.

 
Preferred Qualifications

• Experience in fermentation/Downstream Processing (DSP) and Quality Control.
• Expertise in computerized system validation and implementation.
• Experience providing quality guidance to internal functional teams.

 
This is an exciting opportunity for a Quality Systems expert to make a significant impact by enhancing and optimizing our quality management processes. If you have the required expertise and a passion for quality excellence, we encourage you to apply!

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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