Quality Control Associate
Insmed Incorporated

Job Info

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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 two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Overview

The Quality Control Associate will serve as a strategic and tactical quality professional in ensuring oversight and execution of all aspects of commercial GMP related analytical testing, as well as late stage GMP development testing. Responsible for ensuring timely processing of data produced by internal and contract laboratories and testing performed by manufacturers of all commercial and late stage development products, including starting materials, in-process, release, and stability testing throughout the product lifecycle. • This position will not have direct reports • This role oversees data management of vendors and/or contractors

Responsibilities

• Assists in the oversight of contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve if needed
• Measure performance against established Key Performance Indicators (KPIs), thereby consistently ensuring timely and accurate testing, reporting, and release
• This role will assemble, review and trend release, IPC, and stability data, generating reports as necessary
• Notifies laboratory management when unusual results, trends, or data deviations occur. Assists in composing investigations as it pertains to testing and results
• Assists with documentation formatting. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates.
• Communicating potential issues/obstacles and escalating as necessary
• Assist in the development of new processes and process improvements
• Assist in determining priority of urgent items and appropriate action plan to effectuate priority
• Cross-functional liaison working closely with internal stakeholders
• Provide statistical programming and data management support
• Contributor of statistical analyses and interpret results of these analyses

Qualifications

• The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, or equivalent science program
• Minimum of 2 years of experience in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing
• Knowledge of QC processes and procedures and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulations
• Knowledge of Statistical programming preferred
• Excellent presentation skills both verbal and written
• Highly proficient in Microsoft Office (Word, PowerPoint, Outlook, Teams)
• Ability to define problems, collect data, establish facts, and draw valid conclusions required
• Ability to establish and maintain cooperative working relationships with internal and external partners required
• Ability to take initiative and work independently while effectively managing timelines as required Understand good documentation practices.
• Utilize electronic systems to track and manage information
• Highly organized and self-motivated with a strong attention to detail.
• Experience with Veeva preferred.

Travel Requirements

10%

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $60,000.00 to $78,667.00 per 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 holiday 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.

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