Quality Specialist - QA Operations

Insmed Incorporated
US - New Jersey - Bridgewater
December 1, 2024

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 Sciences 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. Thats why we were named the No. 1 company to work for in the biopharma industry in Sciences 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:
?Responsibilities

Perform 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 & Experience

BS 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.

Qualifications

Must 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

Skills

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 desirable.

Other

10% Domestic/International Travel Requirements
Must successfully exhibit Insmeds 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%

#LI-JT1

Salary Range:
$73,000 - $97,200 a year

Compensation & Benefits:

Were committed to investing in every team members total well-being, now and in the future. We offer a competitive total-rewards package to all e.

Read the full job description and apply online on the recuiter's web-site

Quality Specialist - QA Operations

Quality Specialist - QA Operations

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