Quality Specialist - QA Operations

Company Description :

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases.

Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves.

If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions :

Named Science’s Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients.

That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for three years in a row.

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.

S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

Overview :

Reporting to the Sr. Director, Quality Operations, the Quality Specialist, will play a key role in executing QA activities for Insmed in coordination Quality Operations team.

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 :

ResponsibilitiesPerform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation for drug product and medical devices

Generate certificate of releases, create lots in electronic system, 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

Ensure timely and accurate reporting of quality metrics to management

Participate in cross-functional projects and provide quality assurance expertise and support as needed

Partner with Quality Operations team members and colleagues in other departments to increase the overall effectiveness of the Quality Assurance department and build supportive, productive relationships

Other tasks as assigned by reporting manager

Knowledge & ExperienceBS degree in Chemistry, Life Science or related discipline preferred or equivalent work experience.

Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.

Experience working with an electronic document management system.

QualificationsMust be knowledgeable on cGMP's, ISO 13485, and familiar with other regulatory requirements applicable to a medical device and combination product manufacturing operation.

Experience in batch records review and Product release process

SkillsDemonstrate 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 desirable.

Other10% Domestic / International Travel Requirements

Must successfully exhibit Insmed’s five (5) values : Collaboration, Accountability, Passion, Respect, Integrity.

Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel Requirements :

Up to 10%

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Salary Range :

$73,000 - $97,200 a year

Compensation & Benefits :

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including :

Flexible approach to where and how we work, regionally based

Competitive compensation package including bonus

Stock options and RSU awards

Employee Stock Purchase Plan (ESPP)

Flexible Vacation Policy

Generous paid vacation schedule and winter break

ADDITIONAL U.S. BENEFITS :

401(k) plan with company match

Medical, dental, and vision plans

Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance

Company-provided short and long-term disability benefits

Unique offerings of pet, legal, and supplemental life insurance

Flexible spending accounts for medical and dependent care

Accident and Hospital Indemnity insurance

Employee Assistance Program (EAP)

Mental Health on-line digital resource

Well-being reimbursement

Paid leave benefits for new parents

Paid time off to volunteer

On-site, no-cost fitness center at our U.S. headquarters

Additional Information :

Insmed Incorporated is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source.

Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities;

please contact us directly to be considered for a formal agreement.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.