Specialist, Quality CMC Operations at Insmed Incorporated in NJ Corporate Headquarters

Job description

• 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.

Responsibilities

• In this role, you’ll have the opportunity to 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.

Requirements

• You have a minimum of a Bachelor's degree in Chemistry, Life Science or related discipline as well as at least 3 years’ experience working in a pharmaceutical company. You are or also have:
• Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
• Demontrated experience working with an electronic document management system.
• Must be 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
• Demonstrate ability to manage projects and variable workloads.
• Must have 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).
• Knowledge of Veeva Quality Vault system is highly desirable.

Skills

Required

• Medical devices
• Analytical laboratory practices
• Electronic document management system
• cGMP's and other regulatory requirements
• Batch records review
• Product release process
• Project management

Preferred

• Knowledge of Veeva Quality Vault system

Benefits

• At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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, and meaningful opportunities to connect, volunteer, and give back
• Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
• $39.00-50.00 Hourly