Quality Assurance Specialist Job at Kelly, Washington, DC 20033

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Job Description

Quality Assurance & Control (QA&C) Specialist

Location: Remote

Salary: 100-110k

Position Summary: The Quality Assurance & Control (QA&C) Specialist supports the Research &Development program with a focus on the ongoing development and implementation of quality assurance and quality control aspects of the vaccine analytical, product and process development activities including GXP operations for drug substance/ product production, testing and release of clinical and non-clinical studies materials. The is responsible ensuring that all GXP regulatory requirements and internal quality system management criteria are met before the study products are released for use, assuring ongoing suitability for use during study conduct. The QA&C Specialist provides programmatic support, quality system oversight (including data quality monitoring) and contract service provider oversight. The Quality Assurance and Compliance Specialist will report to the Director, Quality Assurance.

Responsibilities:
  • Provide quality departmental support for development, implementation and execution of study and method protocols, standard operating procedures, summary reports and supporting data; communicate ongoing and final outcomes of quality analytical and drug substance/product, stability and clinical product testing activities
  • Develop and implement electronic system(s) to support data transfer from GXP service providers supporting developmental and regulatory activities as well as the data used for statistical analysis internally and/or externally across all departments
  • Ongoing assessment of data integrity for quality control activities supporting development and regulatory activities; identify gaps and communicate to Sabin R&D staff and collaborators
  • As part of quality systems implementation, ensure quality assurance and quality control points are equipped to ensure checks and balances.
  • Ongoing assessment and evaluation of GXP service providers including sampling processes, procedures, sample integrity and process for recording and reporting the data generated; identify gaps and communicate to R&D staff and collaborators
  • Departmental lead for monitoring testing and inspection of materials and products by contract service providers to ensure identity, strength, purity and quality is maintained
  • Participate in internal and external audits/ inspections including other quality assurance assigned activities
  • Assist in development and implementation of quality system to identify, initiate and monitor corrective and preventive actions to support developmental and regulatory activities
  • Other duties as assigned

Requirements:
  • Bachelor’s degree in a scientific field; master’s degree a plus
  • 7+ years relevant experience, preferably in GXP quality assistance/quality control roles and with broad analytical/bioanalytical method exposure, quality system development and quality incident management
  • Biologics product experience; strong knowledge of vaccine development preferred
  • Demonstrated computerized systems competence, including experience with databases, electronic quality management systems and Microsoft Office
  • Advanced problem-solving abilities and decision-making skills
  • Excellent communication skills, including strong writing abilities
  • Strong interpersonal skills; excellent at building productive working relationships with R&D team members and external collaborators.
• Experience in project execution using virtual platforms (e.g., Zoom/MS Teams) • Strong attention to detail, ability to manage complex tasks; highly organized, flexible, dependable and able to prioritize competing demands in order to meet deadlines
  • Thrive in entrepreneurial, team-oriented work environments; experience working with cross-functional teams Ability to travel domestically and internationally as needed

Attributes that Are Important to the organization:
: • Diversity, Equity and Inclusion • Problem-Solving and Critical Thinking • Decision-Making • Communication and Professionalism • Initiative and Ownership • Productivity and Quality Control • Professional Development/Personal Learning
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.


You should know:

Your safety matters! Visit the COVID-19 Resource Center for the latest information, policies, and frequently asked questions.


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.

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