Manufacturing Specialist – Formulation/Filling Job Listing at Kelly Services in Morrisville, NC (Job ID US3618378_BH10012424)

Description

Manufacturing Specialist – Formulation/Filling

Location: Morrisville, NC

Position Type: Full-Time

Shift: 1st Shift | Monday – Friday, 8:00 AM – 5:00 PM

? High-Priority Opening – Immediate Need

 

Position Summary

This role supports and enhances sterile injectable manufacturing operations, focusing on aseptic formulation and filling processes. The Manufacturing Specialist acts as a subject matter expert (SME) in areas such as isolator-based filling, compounding, dispensing, and visual inspection. The position includes hands-on floor support, investigation of deviations, authoring GMP documentation, and training team members to uphold compliance and ensure process excellence.

Key Responsibilities

• Drive manufacturing readiness and continuous improvement through SOP development, batch documentation, and risk assessments.
• Provide on-the-floor technical support during critical operations including aseptic compounding and filling.
• Lead or support root cause investigations and implement CAPAs related to manufacturing deviations.
• Author and revise SOPs, batch records, and Change Controls in alignment with regulatory standards.
• Facilitate training and qualification processes to maintain consistent operational practices across shifts.
• Support internal and external audits, including client tours and batch-related documentation.
• Collaborate with cross-functional teams to ensure smooth, compliant manufacturing of sterile injectable products.

Focus Area: Formulation/Filling

• Support qualification and expansion of vial/syringe fill line capabilities.
• Maintain and enforce aseptic practices within isolator operations and cleanroom environments.
• Optimize training processes and identify documentation improvements for compounding and filling activities.
• Apply relevant regulatory guidance (e.g., Annex 1, USP, ICH, 21 CFR 210/211) to operational procedures.

Preferred Qualifications

• Bachelor's degree in a scientific or technical field (required).
• Minimum 2 years of experience in sterile injectable manufacturing in a GMP-regulated environment.
• Hands-on experience with aseptic filling operations (preferably using isolator technology).
• At least 1 year of experience in technical writing (SOPs, deviations, batch records, etc.).
• Leadership and/or training experience in a manufacturing environment is a plus.

Candidate Profile

• Preference for candidates who demonstrate stability and progression in previous roles.
• Strong understanding of Good Documentation Practices (GDP) and aseptic technique.
• Familiarity with manufacturing equipment such as autoclaves, filtration systems, isolators, and compounding vessels is desirable.
• Excellent communication and organizational skills with the ability to support cross-functional initiatives.

Compensation & Benefits

• Salary range: $80,000 – $100,000, based on experience.
• 3% annual performance bonus.
• Day 1 benefits, including medical, dental, vision, 401(k) with match, and more.

 

Travel & Physical Requirements

• Up to 5% travel may be required.
• Ability to lift/move up to 75 lbs with assistance.
• Work performed in cleanroom environments; PPE and respirator use (e.g., PAPR) may be required.

 

This is a high-priority role with an immediate opening. If you have a strong foundation in sterile injectable manufacturing and aseptic processes, we encourage you to apply.

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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