Quality Assurance Specialist

Quality Assurance Specialist

Overview

This QA Specialist will be responsible for assisting and providing quality and compliance oversight for implementing, validating and maintaining electronic systems in accordance with existing corporate policies, procedures and existing FDA and other health agency regulations to ensure compliance of these global electronic systems.

Key Responsibilities

• Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer systems validation (CSV) procedures and requirements.
• Provide QA oversight during regulatory assessments, risk assessments, 21 CFR Part 11 and Annex 11 assessments.
• Provide QA support as a QA Lead for IT infrastructure qualification at Corporate and other manufacturing facilities including Alewife, Norton etc.
• Develop or Review Validation Plans, Specifications, Test scripts, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, Trace Matrices and Summary Reports associated to computer systems.
• Execute or review validation protocols/test scripts and applicable discrepancies associated to computer systems.
• Support and review system administration and maintenance procedures to ensure computer systems are in a state of control
• Assist QA and IT department in developing, reviewing and/or updating Standard Operating Procedures to support continuous improvement for the CSV processes
• Provide QA oversight during gap analysis of existing validation documentation against continuous improvements, and support the remediation of the gaps
• Review changes to validated state of systems through change control procedures and participate in the planning and implementation of changes
• Provide QA support for periodic review of computer systems to ensure compliance and maintenance of the computer system in a validation state.
• Review and support business and IT to act as QA for Deviations and CAPA associated with Corporate IT Systems
• Support internal and external audits that may potentially include travel to on-site vendor audits. Assist the lead auditor to generate Audit Reports.
• Provide support in Inspection and Partner audits as QA in preparing SMEs, backroom, and front room support.
• Performs other quality and CSV related duties as necessary.
• The candidate will act as the quality contact to oversee and provide QA support during implementation and validation of new systems and managing changes to existing validated system.

Qualifications

• Bachelor’s with 3-5 years or a Master’s with 1-2 applicable QA or CSV experience.
• Basic knowledge and understanding in principles of computer systems validation in the Pharmaceutical industry using the ISPE GAMP5 model to meet GxP requirements and applicable regulations (e.g. 21 CFR Part 11, Annex 11 etc.) is highly desirable.
• The candidate should have the ability to work closely and collaboratively with various business partners (internal/external customers and vendors) globally including Information Technology (IT), system owners, vendors to provide appropriate QA support during implementation, validation, system upgrades, and/or system modifications of computer systems.
• The candidate should have the ability to support multiple projects or tasks at the same time. The person must be able to work in a fast-paced environment with good interpersonal skills.
• Good organizational, communication, and interpersonal skills
• Effective oral and written communication skills.
• Have a good understanding of using Microsoft Office Suite (e.g., Word, Excel, Project, Visio, and PowerPoint).
• Good understanding of global regulations (e.g. FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines etc.) around quality systems and CSV in Biotech and/or Pharmaceutical industry
• Experience as a QA or CSV Validation professional within the Pharmaceutical industry will be a Plus
• May require travel up to 15% domestically and 10% internationally.

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 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 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.