Job Title: Manufacturing Specialist - Visual Inspection / Training Coordinator
Location: Morrisville, NC
Employment Type: Full-Time, Direct Hire
Schedule: 1st Shift | Monday - Friday, 8:00 AM - 5:00 PM
Salary Range: $80,000 - $100,000/year
About the Role:
We're currently recruiting for a Manufacturing Specialist with a strong background in sterile injectable production, visual inspection, and training coordination. This is a hands-on, subject matter expert (SME) role supporting critical operations in a fast-paced GMP manufacturing environment.
The ideal candidate will be responsible for driving continuous improvement in manufacturing operations, particularly in the areas of aseptic processing, visual inspection, documentation, and personnel training.
Key Responsibilities:
Serve as SME for manufacturing processes including dispensing, compounding, isolator filling, and visual inspection.
Develop and maintain SOPs, batch records, and risk assessments to support GMP manufacturing.
Conduct root cause investigations and implement CAPAs for process deviations.
Lead employee training and qualification programs to ensure consistent manufacturing practices.
Support documentation for audits, change controls, annual reports, and training records.
Oversee visual inspection processes for syringes, vials, and lyophilized products.
Coordinate with cross-functional teams (QA, Engineering, Technical Services, etc.) to ensure batch readiness and release.
Provide on-the-floor support during critical operations and process changes.
Use SAP or similar systems for inventory tracking and sample management.
Required Qualifications:
Bachelor's degree in a related field + 2 years of relevant experience
At least 1 year of technical writing experience (SOPs, deviations, batch records, etc.).
Demonstrated experience in training and mentoring manufacturing personnel.
Preferred Skills & Experience:
Strong understanding of cGMP and Good Documentation Practices (GDP) .
Experience with USP Annex 1 and sterile processing best practices.
Familiarity with equipment such as:
Light inspection booths & TAPPI charts
Compounding and filtration equipment
Isolator-based drug product fillers
Ability to manage discrepancies using tools like AARs, fishbone diagrams, and 6M methodologies.
Comfortable with Microsoft Office and electronic documentation systems.
Work Environment & Expectations:
This is a 100% on-site position.
Occasional weekend or holiday work may be required to support operations.
Candidates should be comfortable working in controlled cleanroom environments .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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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.
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.
