Senior Quality Assurance Specialist

Sr. Quality Assurance Specialist Louisville, CO

Type : Contract (6 months potential for extension / conversion)

Shift : M-F 8a-5p

Pay Rate : $46-$55 / hr

Position Summary

We are seeking a Contract Quality Assurance (QA) Sr. Specialist to support deviation investigations related to Good Manufacturing Practice (GMP) operations at our state-of-the-art lentiviral vector development and manufacturing facility in Louisville, CO.

Responsibilities

• Independent triage of potential non-conforming events to assess immediate corrections, need for subsequent deviation, and assign criticality in alignment with procedures.
• Identification and assembly of cross-functional teams to achieve defined investigation milestones.
• Utilization of appropriate root cause analysis tools commensurate with the level of investigational complexity and criticality.
• Execution and management of investigations and deliverables within the electronic Quality Management System (eQMS) in accordance with defined requirements.
• Timeline management of deviation corrections, corrective actions, and / or preventive actions.
• Proactive communication and escalation of risks associated with investigations.
• Providing investigation updates to site management and cross-functional business reviews.
• Providing feedback and actively participating in deviation program metrics establishment and continuous improvement.
• Potential to mentor / train investigators.
• Potential to assist in developing investigation training material.
• Potential to cross-train within the Quality Assurance organization to provide Quality oversight and support across other GxP tasks and programs.
• Potential to support QC laboratory investigations.
• Other duties, as assigned.

Qualifications

• Bachelor's degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, other life science, or related field.
• Minimum of 8 years of work experience in an FDA regulated industry, or a similar combination of education and experience.
• Previous experience performing and supporting deviation investigations in a cGMP biopharmaceutical manufacturing facility operations environment.
• Proficient technical writing and communication skills with a proven ability to summarize complex, technical topics into easily digestible formats.
• Excellent project management skills.
• An understanding of quality management systems within an early-phase GMP environment.
• Knowledge of relevant pharmaceutical regulations and regulatory guidance.
• Understanding of risk management principles and philosophy within the quality system in support of first-in-human and Phase 1 products / programs.
• Strong communication and organizational skills, and a passion for teamwork.
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas with minimal supervision.

Preferred Qualifications

• Experience performing QC laboratory investigations in a cGMP biopharmaceutical manufacturing facility operations environment.
• Experience in cGMP cell and gene therapy manufacturing and / or testing facility.

Physical Requirements

• Ability to gown aseptically and work in a Clean Room environment, if required.
• Ability to work while gowned for extended periods of time, if required.
• Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required.
• Use of laboratory equipment includes handling chemicals and biological materials.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work occasional nights and weekends as needed.

For Immediate Consideration - Apply Today!

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.

At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.