Specialist, Quality CMC Operations
About The Position
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: Reporting to the Sr. Director, Quality CMC, the Quality Specialist will play a key role in executing QA activities for Insmed supporting Phase 1- 3 pipeline products. Specific areas of responsibility include Batch Record Review, Product Release process, CoA review, CoR generation, QA Metric monitoring, in addition to other QA related activities.
Requirements
- Minimum of a Bachelor's degree in Chemistry, Life Science or related discipline
- At least 3 years’ experience working in a pharmaceutical company
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Demonstrated experience working with an electronic document management system.
- Knowledgeable on cGMP's and other regulatory requirements applicable to GMP product manufacturing operation and release.
- Proven experience in batch records review and product release process
- Ability to manage projects and variable workloads.
- Excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Nice To Haves
- Knowledge of Veeva Quality Vault system is highly desirable.
Responsibilities
- Perform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation for pipeline drug substance, drug product and medical devices.
- Generate certificate of releases, create lots in electronic system and upload all required documents for internal and external stakeholders.
- Ensure compliance with all relevant regulations and guidelines related to pharmaceutical quality and batch disposition.
- Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance and batch disposition processes.
- Develop and maintain standard operating procedures (SOPs) for batch disposition and quality assurance processes.
- Communicate with external suppliers and internal stakeholders regarding quality-related matters.
- Maintain accurate and organized records of all quality assurance and batch disposition activities.
- Participate in cross-functional projects and provide quality assurance expertise and support, as needed.
- Partner with Quality CMC team members and colleagues in other departments to increase the overall effectiveness of the Quality Assurance department and build supportive, productive relationships.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- Company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups
- Service and recognition programs
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
