<p>Job Title: Quality Sample Coordinator</p> <p>Job Description</p> <p>The Quality Sample Coordinator will oversee and confirm compliance in compounding processes, including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, and autoclave procedures. This role involves coordinating samples for clean rooms, verifying proper gowning by all personnel, and monitoring environmental activities. You will generate deviations, issue CAPAs, and manage change controls in response to observations. Additionally, you will collaborate with Quality Assurance Management on quality issue tracking, trending activities, batch record review, batch release, visual inspection, and other tasks assigned by management.</p> <p>Responsibilities</p> <ul> <li>Oversight and confirmation of compliance in compounding processes. </li><li>Coordination of samples for clean rooms and verification of proper gowning. </li><li>Verification of environmental monitoring activities, including plating and personnel monitoring. </li><li>Generation of deviations and issuance of CAPAs and Change Controls. </li><li>Follow-up on quality issue tracking and trending activities. </li><li>Batch record review and batch release. </li><li>Visual inspection and participation in regulatory audits. </li><li>Assist process owners with root cause analysis. </li><li>Prepare and monitor Quality Metrics and KPIs. </li><li>Perform duties in accordance with established company procedures and policies. </li></ul> <p>Essential Skills</p> <ul> <li>3+ years of experience in aseptic drug product manufacturing. </li><li>2 years of aseptic experience within a GMP lab. </li><li>Fundamental knowledge of safety, quality systems, and quality assurance concepts. </li><li>Strong familiarity with manufacturing process and operations, automation, and equipment validation. </li><li>Familiarity with FDA inspections and audits. </li><li>Investigation writing skills. </li><li>Ability to complete tasks with little direction or supervisory follow-up. </li><li>Strong written, verbal, and presentation communication skills. </li><li>Strong computer skills in database management and documentation preparation. </li><li>Ability to think creatively and confront new issues. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Knowledge of current Good Manufacturing Practices (cGMP) guidelines. </li><li>Close visual acuity for defect inspection. </li><li>Attention to detail. </li><li>Proper use of personal protective equipment and aseptic procedures. </li><li>Accurate completion of production documentation and logbooks. </li></ul> <p>Work Environment</p> <p>This position is part-time, working 30 hours per week on the first shift from 8am to 4:30pm. You will work in 503B clean rooms alongside the Quality Team, ensuring compliance with company safety policies, cGMP, and SOPs. The role offers exposure to different departments and a great opportunity to learn about GMP practices. You will be working hands-on with manufacturing production equipment and technologies in ISO7, ISO8, and other classified areas.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $24.00 - $25.00/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job</p> <p>classification and length of employment. Benefits are subject to change and may be</p> <p>subject to specific elections, plan, or program terms. If eligible, the benefits</p> <p>available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Ledgewood,NJ.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Jul 14, 2025.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>