Quality Packaging Operations Specialist Job Listing at Kelly Services in Hanover, NJ (Job ID US3534000_BH9728582)

Description

Job Title: Project Specialist, Quality Operations- Whippany, NJ 07981
Job Summary:
The Project Specialist, Quality Operations will oversee activities at a contract packaging facility for approximately 8- 12 months+, with a focus on managing the packaging operations for commercial and new product launches. The role includes providing guidance and support to ensure compliance with 21 CFR Part 4 requirements in alignment with new product launch activities. The incumbent will be responsible for overseeing the quality operations, managing quality systems, and addressing CAPA at the Contract Packaging Organization (CPO). The role involves ensuring compliance with applicable company policies and regulations while collaborating with cross-functional teams to achieve project goals. Scope of Authority:

• Responsibility: Quality oversight for CPO Quality Operations and Quality Systems, including CAPA activities at the CPO.
• Project Management: May manage specific projects or serve as the Subject Matter Expert (SME)/Process Owner for particular tasks on-site.
• Collaboration: Work closely with internal teams and Dublin office to ensure alignment and compliance with quality systems and regulations.

Key Accountabilities:
1. Quality Oversight (50%)

• Witness line setup and ensure compliance with approved packaging records.
• Monitor packaging operations to ensure adherence to Good Manufacturing Practices (GMP).
• Verify that no ad-hoc deviations or tasks are undertaken by the CPO outside of the Master Packaging Records (MPR) requirements.
• Ensure general GMP compliance across the site.

2. Quality Systems Oversight (30%)

• Act as the first point of review for deviations, Corrective and Preventive Actions (CAPAs), and change controls to ensure they align with GMP requirements.
• Collaborate with Dublin office to review and provide feedback on QMS records for the CPO.
• Ensure proper documentation and adherence to quality standards.

3. New Product Launch Readiness (20%)

• Participate in cross-functional teams to prepare for new product launch activities.
• Take action on required activities identified by the team with the CPO.
• Provide oversight to the activities undertaken by the CPO to ensure timely and compliant product launches.

Qualifications:
Education & Experience:

• Bachelor's degree in a scientific-related field.
• Minimum of 10 years of cGMP experience, required.
• Previous experience working for pharmaceutical, biopharmaceutical, or sciences industry.
• Experience in packaging operations is highly preferred.
• Technical and quality background related to the sciences is essential.

Knowledge:

• Strong knowledge of FDA regulations, GMP/GLP/GCP, and Lean Manufacturing principles.
• Expertise in 21-CFR-210, 21-CFR-211, and ICH Guidelines.
• Familiarity with EU GMPs, ISO standards, and other relevant regulatory requirements.

Physical Requirements:

• Routine office work (sitting/standing) with some physical oversight required in packaging lines.
• Ability to conduct Gemba walks on the packaging floor to ensure quality standards are maintained.

This position offers the opportunity to play a key role in overseeing quality operations for new product launches, ensuring the highest standards of GMP compliance while working closely with internal teams and the CPO.
 

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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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