Quality Assurance Records Senior Specialist Job Listing at Kelly Services in Louisville, CO (Job ID 10074756)

Description

Kelly® Science & Clinical is seeking Quality Assurance Records Senior Specialist for a contract position for a company in Louisville, CO. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Overview:
This role is responsible for thoroughly investigating manufacturing-related quality events and delivering well-documented deviation investigation records.  The Quality Assurance Records Sr. Specialist will also own change control records and will be expected to manage continuous improvement initiatives that enhance GMP efficiency

Pay Rate: 
$52-64/hr Depending on experience

Schedule & Duration: 
Monday-Friday Day Shift, approx. 6 months

Responsibilities:

• Own end-to-end deviation investigations and effectively collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification
• Ensure clarity, accuracy, and compliance of quality event documentation that meets procedural, regulatory, and phase-appropriate expectations
• Deliver high-quality deviation investigation reports that are complete, concise, clear, and submitted within defined timelines
• Own change control records and manage effective execution and closure by drafting organized, well-structured change action plans and driving implementation.
• Manage continuous improvement initiatives from concept through execution by tracking progress with owners and stakeholders
• Communicate status of investigations, quality event records (Deviations, Change Controls, CAPAs) and Continuous Improvement projects at cross-functional and manufacturing-specific group meetings

Qualifications:

• Bachelors in Biochemistry, Cell & Molecular Biology or related Life Science discipline
• Minimum of 8 years of experience with deviation investigation and complex root cause investigational tools (e.g., fishbone, 6M) 

• Ability to gown aseptically and work in a Clean Room environment and Ability to work while gowned for extended periods of time, including standing for extended periods of time.

• Demonstrated ability to use risk-based decision-making in support of deviation investigation and quality event reporting
• Excellent written and verbal communication skills, with the proven ability to deliver clear, concise reports in a GMP manufacturing environment
• Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously

What happens next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in the Kelly Science & Clinical network. That means our team of expert science & clinical recruiters will have access to your profile, making your opportunities limitless.

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, short-term disability, 401(k) retirement savings plan, service bonus plan, and a transportation spending account. In addition, this position offers employees the ability to earn up to forty hours of paid time off after 6 months and be eligible for paid holidays per benefit year. Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.”
 

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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