Kelly Services Quality Assurance Associate in Cambridge, Massachusetts
Title: Quality Assurance Associate
Location: Cambridge, MA 02142
Duration: 6 months contract; possibly longer for the right candidate
This person is responsible for managing the quality interface with packaging and testing partners for clinical small and/or large molecules, early to late phase for finished drug products.
This person will be the primary quality contact for onboarding new clinical assets, product / process transfer, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management. This person will lead and/or support continuous improvement initiatives related to QMS and procedures for CMO and partner oversight. This person will be the primary quality contact for onboarding and CMO oversight.
This position collaborates with internal and external functions such as External Manufacturing Operations, Clinical Supply Chain, Label Development, Planning & Logistics, Regulatory Affairs, Product Development Quality and Technical Development to ensure compliance with cGMP regulations and QMS.
Success in the role requires a strong knowledge in quality operations and in the application of phase appropriate, risk-based quality principles. Success in this role requires an ability to develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.
•Ensure efficient and effective use of time to support priorities and drive for results
•Oversee quality aspects of GMP activities for clinical product packaged, stored, and distributed, through CMO network. Activities include product disposition, quality support packaging operations, exceptions management, change control, risk management, technology transfer and validation
•Provide Quality expertise to influence tactical decisions needed to package and disposition product in a compliant manner to GMPs
•Support initiatives to improve systems/processes in Global Quality with a goal of compliance, efficiency and standardization
•Perform risk assessments in response to product / quality system failures, investigations and regulatory inspections
•Perform tasks and makes decision consistent with cGMPs, GDPs and quality governance
•Collect and perform trend analysis for KPIs
•Additional duties as assigned
• Minimum of 2 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 5 years in clinical and or commercial quality operations.
• Experience in quality operations as it relates to unit operations for the manufacture of either one or more of the following modalities: Parenteral, Oral Solid Dosage Form, ASOs.
• Experience working with third-party GMP vendors.
• Comprehensive knowledge of GMP and GDP regulations and subsequent applications to pharmaceutical drug manufacturing, and or packaging and distribution.
• Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
• Experience in contributing to regulatory filings and inspections preferred.
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
About Kelly ®
At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
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