Sr. Specialist, External Quality Small Molecules Job Listing at Kelly Services in Hopewell Township, NJ (Job ID US3577875_BH9879839)

Description

Sr. Specialist, External Quality Small Molecules (Remote)

Manager or Sr Specialist, External Quality Small Molecules

In this position you will provide end to end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:

• Provide quality support to ensure effective execution of quality systems at external manufacturing sites.
• Support quality oversight in the qualification and ongoing monitoring of external partners.
• Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Provide support to the escalation and issue management processes.
• Review and approve quality systems documentation, including batch documentation and annual product reviews.
• Assess change controls and execute activities for implementing changes.
• Review and approve validation documentation, technical studies, master batch records and specifications. Establish and maintain quality agreements.
• Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
• Build relationships with internal and external partners to meet patient supply requirements.
• Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions.
• Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.
• Provide quality oversight for integration of external manufacturing facilities. Support a variety of projects both internally and with external manufacturers.

Qualifications:

Education:

• A minimum of a Bachelor's or equivalent University degree is required. A focus in life science, engineering, or physical science preferred.

Experience and Skills:

Required:

• A minimum of 8 years working in a cGMP regulated environment for Manager Level
• A minimum of 5 years working in a cGMP regulated environment for Sr Specialist Level
• Experience supporting quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation.
• Ability to work independently in support of a portfolio of products and external manufactures.
• Experience working on cross-functional project teams.
• Strong communication and influencing skills; demonstrates an ability to communicate at all levels of the organization.

Preferred:

• Experience working with external partners.
• Experience with product transfer, new product introduction, and combination products.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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