Senior Quality Assurance Associate

Alnylam Pharmaceuticals; Kansas; On-site; USD 70,000 - 90,000; Full time

Job summary

Join a leading company in biotechnology as a Senior Quality Assurance Associate at their Norton Manufacturing Facility. The role involves providing QA operational support, ensuring adherence to quality systems, and participating in audits and inspections. Ideal candidates will have a Bachelor’s degree and substantial experience in QA operations within a GMP environment.

Qualifications

• A minimum of 3 years of QA operations experience in a GMP manufacturing facility.
• Excellent understanding of FDA, EMA regulations and ICH guidelines.
• Experience in Early Phase Clinical GMP Operations.

Responsibilities

• QA review and approval for deviations, CAPAs, change controls, and PM Plans.
• Perform batch record review and disposition of Active Pharmaceutical Ingredients.
• Lead partner audits and regulatory inspections.

Skills

Organizational skills

Communication skills

Interpersonal skills

Education

Bachelor’s degree in sciences or engineering

Tools

Electronic Quality Management Systems

Electronic enterprise resource planning systems

Electronic calibration and maintenance systems

Job description

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Overview

The Senior Associate, Quality Operations QA will provide on site QA Operational support from Monday – Friday during the hours of 8 AM – 4 PM at Alnylam’s Norton Manufacturing Facility. This role will support on the floor manufacturing operations, Batch Disposition and Release as well as Audits and Inspections. The position will perform area and equipment change overs, perform batch record review, disposition of API and/or Raw Material and triage deviation events to enable manufacturing operations to continue uninterrupted.

Overview

The Senior Associate, Quality Operations QA will provide on site QA Operational support from Monday – Friday during the hours of 8 AM – 4 PM at Alnylam’s Norton Manufacturing Facility. This role will support on the floor manufacturing operations, Batch Disposition and Release as well as Audits and Inspections. The position will perform area and equipment change overs, perform batch record review, disposition of API and/or Raw Material and triage deviation events to enable manufacturing operations to continue uninterrupted.

Key Responsibilities

• QA review and approval for deviations, CAPAs, change controls, PM Plans, Work Orders
• QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch record review/approval, and raw material disposition process
• Performing Area Clearance and Change over operations for manufacturing facility
• Lead disposition of Active Pharmaceutical Ingredients
• SOP generation and ownership for Quality related functions
• Ensure adherence to Quality systems for internal manufacturing facilities
• Partnering with the internal cross functional groups at the Norton facility to develop and maintain the programs through SOP creation and revision process
• Provide QA support in partner audits and regulatory inspections
  
  

Qualifications

• A minimum of Bachelor’s degree in sciences or engineering
• A minimum of 3 years of QA operations experience in a GMP manufacturing facility
• Experience in Early Phase Clinical GMP Operations
• Excellent understanding of FDA, EMA regulations and ICH guidelines
• Excellent organizational, communication, and interpersonal skills
• Experience with electronic Quality Management Systems
• Experience with electronic enterprise resource planning systems
• Experience with electronic calibration and maintenance systems
  
  

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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