Quality Control Analyst I

Overview

The Quality Control Operations Microbiology Analyst I plays a role in supporting the department's efforts to maintain the highest standards of quality and compliance, from development through commercialization. In addition to executing routine and non-routine microbiology sampling and testing in support of development through commercial programs, the Microbiology Analyst I may participate in data trending, investigations, and other laboratory operations.  By ensuring these critical activities are executed within project milestones and timelines, the Microbiology Analyst I contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.

This position is onsite and will be primarily located in Norton, MA.  There may be occasional responsibilities at a secondary location in Cambridge, MA.

Key Responsibilities (including but not limited to):

• Perform role-specific operational assignments (e.g., environmental monitoring and critical utility sampling in CNC and Grade C/D cleanroom spaces, product testing, etc.)
• Perform routine and non-routine microbiological assays (i.e., Bioburden, TOC, Conductivity, Endotoxin, microbial identification via MALDI-TOF) with increasing complexity, to support raw materials, critical utilities, in-process samples, product release, and stability studies, following established SOPs
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
• Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
• Ensure data is submitted timely; may qualify as a data reviewer to ensure timely and efficient data availability.
• Contribute to the revision and updating of controlled documents as needed, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with ALNY requirements
• Assist in deviation investigation, corrective action implementation, method improvements
• Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data with input from Supervisor; provide recommendations to non-routine issues
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed
• Support continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness
• Collaborate with other organizational functions including Manufacturing, Materials Management, and Quality Assurance to ensure alignment with overall business goals

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field; Associates Degree, Biotech Certificate, or equivalent considered
• Pharmaceutical/Biotech industry experience with 1 year in a regulated laboratory setting, Quality Control, or equivalent, relevant experience   
• Familiarity with performing EM and CU sampling and testing
• Familiarity with Compressed Gas and Water for Injection Systems
• Familiarity or experience with standard microbiology testing (Bioburden, TOC, Conductivity, Endotoxin)
• Familiarity of compendial requirements (USP, Ph. EUR, and JP)
• Data analysis experience preferred
• Ability to work under direction with attention to detail, in an environment where priorities shift
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful
• Ability to travel between domestic sites (Norton, MA, Cambridge, MA)

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.