• Quality Assurance Specialist

    System One (Exton, PA)


    Job Title: Quality Assurance Specialist

     

    Hours/Schedule: Monday-Friday, 8:00AM-5:00PM

     

    Type: 6-Month, Contract-to-Hire

    Overview

    We’re looking for a Quality Assurance Specialist ready to make an impact at a fast-growing sterile drug manufacturer in Exton, PA. This is an excellent opportunity for an experienced QA professional who enjoys rolling up your sleeves, driving compliance improvements, and jumping in wherever needed. You’ll be part of a small, agile team in a 503B compounding environment where your ideas, initiative, and cross-functional mindset will directly shape the company’s success.

    Responsibilities

    + Drive improvements to the Quality Management System by introducing new ideas to enhance efficiency, compliance, and inspection readiness

    + Create, revise, and maintain SOPs and other controlled documents to ensure alignment with FDA, USP, and GMP standards

    + Support QC operations as needed, including environmental monitoring, cleanroom activities, and batch documentation

    + Review and approve deviations, CAPAs, investigations, and change controls to ensure timely resolution and compliance

    + Assist with validation activities for processes, products, and equipment in support of manufacturing and quality goals

    + Conduct and support internal and supplier audits, maintaining accurate records and implementing corrective actions

    + Participate in regulatory and customer inspections and help maintain a state of continuous inspection readiness

    + Collaborate across departments on compliance activities such as product recalls, complaint investigations, and state licensure renewals

    + Track and trend quality metrics to identify process improvements and support management review meetings

    Requirements

    + Bachelor’s degree in a scientific discipline

    + 5+ years of Quality Assurance experience within a GMP manufacturing environment

    + Prior experience in a 503B compounding facility - required

    + Demonstrated knowledge of QMS implementation and regulatory frameworks (21 CFR Part 11, 210, 211)

    + Experience with SOP creation, modification, and document control

    + Ability and willingness to support cleanroom operations and QC functions as needed

    + Proven ability to work independently and cross-functionally in a small, fast-paced start-up team

    + Must be legally authorized to work in the United States for any employer

     

    Benefits

     

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan

    #M-3

    #LI-MM1

    #DI-

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.