Quality Assurance Scientist I

Quality Assurance Scientist I page is loaded

Apply locations Boulder, Colorado, USA time type Full time posted on Posted 8 Days Ago time left to apply End Date: January 17, 2025 (12 days left to apply) job requisition id JR100949

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

One Colorado, one team. At our Boulder and Longmont locations, we cultivate a unified team under the banner of 'One Colorado', fostering collaboration among diverse teams and their respective business units. Together, we leverage a shared services objective between the two sites to enhance care for our clients and their patients.

SUMMARY:

The QA Scientist I, Product Quality Lead (PQL) is a full-time position located at the AGC Biologics facility in Boulder, Colorado. The primary focus for this role is to provide technical expertise and project leadership to the Quality organization and to engage as a product quality expert with Core Teams, Manufacturing, Quality Control, MSAT, Regulatory, and other departments for a variety of activities with one or more products. The PQL will act as the main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle for both internal and external customers. Additionally, the PQL will act as the point of contact for major and critical investigations, ensuring all reports performed are scientifically sound and well written. The ideal candidate will possess a scientific background to help in the resolution of issues associated with Manufacturing or any other critical process at AGC Biologics.

KEY RESPONSIBILITIES:

• Provides cross-functional quality leadership and supports program deliverables for one or more products/molecules and associated ongoing life-cycle management activities including product transition from clinical to commercial, new product introductions, and technology transfers for the site.
• Provides quality perspective, expertise, and decisions as Quality representative on product cross-functional teams.
• Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.
• Acts as the Customer point of contact for quality oversight for one or more products at different stages of the product lifecycle.
• Provides guidance and Quality input to GMP decision making for day-to-day operations.
• Recognizes key product quality risks and ensures timely escalation of the identified risks to the right levels of the organization.
• Leads Quality Core Team meetings, provides metrics, and discusses agenda topics with clients.
• Provides technical expertise and recommendations relating to product quality and influences solutions.
• Reviews and approves product-related deviations, change controls, CAPA, and product-specific GMP documentation (protocol, report, technical memo).
• Exercises independent judgment in interpreting and applying regulations to GMP systems. May make recommendations for QA policies and procedures. Interprets complex regulations and guidelines critical for advancing and improving the QA systems.
• Leads efforts to identify and implement processes and procedure optimization to facilitate compliance.
• Accountable for decisions and results that promote the efficiency of the processes at ACG and increase the customer satisfaction level with the internal and external clients.
• Supports science and risk-based evaluation of complex processes and product quality data, including the ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues.
• Contributes to the annual product review and may be a reviewer/approver.
• May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression. May act as an advisor to multiple project teams.
• Responsible for making recommendations and decisions in accordance with federal and international regulatory requirements and industry standards.
• Ideally, but not strictly required, the candidate should possess scientific background and expertise in areas such as Quality Control (i.e. testing profiles and Laboratory Investigations) and be familiarized with the Manufacturing and Development processes.
• The candidate should be familiar with Operational Excellence tools (i.e. Kaizen, Value Stream Mapping, etc.), basic Risk Management techniques, and their applicability in the pharmaceutical industry.

KNOWLEDGE, SKILLS & ABILITIES:

• Experience working in a regulated environment (either direct GMP or technical role supporting GMP).
• Strong technical and analytical understanding of Biologics Manufacturing and testing.
• Demonstrated technical aptitude and experience with biologic drug tech transfers, analytical methods, and commercialization.
• Expert knowledge of GMP and regulatory submission requirements.
• Knowledge in Operational Excellence and Risk Management.
• Proven leadership ability to manage challenging decisions in a logical and compliance manner, with a demonstrated ability to influence team members in a cross-functional environment and effectively communicate with senior management.
• Must be self-motivated, organized, and proactive.
• Proven experience successfully managing multiple projects simultaneously.
• Demonstrated ability to build effective working relationships across departments (Manufacturing, QC, MSAT, Process Development, Project Management, and Business Development) to support new processes and products.
• Demonstrated experience leading troubleshooting efforts in regards to quality decisions.
• Strong communication skills necessary to interact with internal and external stakeholders.
• Strong presentation skills.

EDUCATION/EXPERIENCE:

• BA, BS or advanced degree in Life Sciences or Engineering required.
• Minimum of:
  • Scientist I: 5+ years of experience in the biotechnology or pharma industry with experience in biologics with a BS/BA or 2+ years with a MS/MA.
• Experience with client interfacing is preferred.
• Knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals.
• Must have experience writing, reviewing, approving, and managing GMP documentation and quality system events. Direct QA experience is preferred.
• Equivalent education and experience may substitute for stated requirements.

COMPENSATION RANGE:

$83,920 - $115,390

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit

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AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit