What are the responsibilities and job description for the Senior Manager, Quality Operations-Weekend Shift position at Alnylam Pharmaceuticals?
This role is considered On-Site.
Overview
The Senior Manager QA Operations Weekend shift will provide on site QA Operational support from Friday – Monday during the hours of 10 AM – 9 PM at Alnylam’s Norton Manufacturing Facility. This role will support on the floor manufacturing operations as well as supporting QC Laboratory operations as needed to ensure management coverage during the time when onsite QC Management support is not available. The position will perform area and equipment change overs, perform batch record review, disposition of API and/or Raw Materials. The Sr Manager will triage deviation events to enable manufacturing operations to continue uninterrupted.
Key Responsibilities
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.
Overview
The Senior Manager QA Operations Weekend shift will provide on site QA Operational support from Friday – Monday during the hours of 10 AM – 9 PM at Alnylam’s Norton Manufacturing Facility. This role will support on the floor manufacturing operations as well as supporting QC Laboratory operations as needed to ensure management coverage during the time when onsite QC Management support is not available. The position will perform area and equipment change overs, perform batch record review, disposition of API and/or Raw Materials. The Sr Manager will 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
- Independently providing forward processing decisions during manufacturing discrepancies
- 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
- Assist QC staff with overseeing routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs when needed.
- Assist QC staff with timely and accurate data review, qualifying as a data reviewer to expedite the availability of results for critical decision-making when needed
- A minimum of Bachelor’s degree in sciences or engineering
- A minimum of 10 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
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.
