GMP Manufacturing Associate I

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best. ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world. Working as one to help many. WHY THIS ROLE MATTERS The mission of the GMP Manufacturing Operator is to safely and accurately produce drug products and combination devices that patients and clients can rely on. This role performs the hands-on assembly, packaging, and cleaning work on the GMP manufacturing floor, following approved batch records and procedures to get each batch done right the first time while keeping manufacturing areas inspection-ready. The position requires strong attention to detail, a commitment to product quality, and the discipline to follow cGMP requirements and Good Documentation Practices consistently. Working under the direction of senior production staff, the Operator is the first line of defense for product quality, safety, and compliance. The GMP Manufacturing Operator supports ProMed’s mission and values by ensuring the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work. WHAT YOU’LL ACHIEVE While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are: On average, this will represent about 35% of your time. In this aspect of your position, we will expect you to: Read, understand, and follow approved batch records, work instructions, and standard operating procedures (SOPs) used in the production of drug products and combination devices. Perform manual and semi-automated assembly operations. Perform primary and secondary packaging activities, including kit assembly, labeling, and cartoning. Perform in-process inspections and quality checks as required by production procedures. Line Setup, Changeover & Material Readiness On average, this will represent about 15% of your time. In this aspect of your position, we will expect you to: Conduct line setup, changeovers, and line clearance activities. Verify availability and accuracy of materials, components, equipment, and production documentation before initiating manufacturing activities. Reconcile components, labels, and finished goods according to established procedures. On average, this will represent about 20% of your time. In this aspect of your position, we will expect you to: Adhere to gowning requirements and contamination control practices for controlled manufacturing areas. Perform cleaning and sanitization of manufacturing equipment, tools, production rooms, and controlled environments. Maintain a clean, organized, and inspection-ready work environment consistent with GMP housekeeping standards. GMP Documentation On average, this will represent about 20% of your time. In this aspect of your position, we will expect you to: Complete production records, logbooks, cleaning records, and other documentation accurately and in real time in accordance with Good Documentation Practices (GDP). Correct documentation errors promptly when identified by leads, supervisors, or Quality reviewers. Training, Compliance & Escalation On average, this will represent about 10% of your time. In this aspect of your position, we will expect you to: Maintain the training and qualifications necessary for assigned manufacturing operations. Escalate equipment malfunctions, process deviations, and quality issues to supervision and Quality Assurance personnel. Meet expectations of regular, reliable attendance. Perform other duties and tasks as deemed necessary and appropriate. Necessary Expertise and Skills: Ability to read, understand, and follow SOPs, batch records, and work instructions in English. Ability to accurately complete GMP documentation following Good Documentation Practices (GDP). Strong attention to detail and commitment to product quality. Fine motor skills in hands and wrists and good hand/eye coordination. Basic computer skills. Ability to work independently within established procedures and to meet deadlines and priorities. MINIMUM REQUIREMENTS Minimum Qualifications For The Role: High school diploma or equivalent required. 1+ year of experience in pharmaceutical, biotechnology, medical device, food manufacturing, or other regulated manufacturing environment. Preferred Qualifications: Experience in a pharmaceutical manufacturing environment. Experience with combination drug product assembly and packaging operations. Experience with visual inspection, including manual and automated systems. Experience using a microscope/reticle. Experience working in controlled manufacturing environments or cleanrooms. Knowledge of pharmaceutical cGMP standards and Good Documentation Practices. Physical, Sensory, Cognitive & Neurological Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role, including standing, sitting, walking, stooping, bending, squatting, kneeling, reaching, grasping, lifting, pushing, pulling, and repetitive movements for extended periods. Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including standing, sitting, walking, stooping, bending, squatting, kneeling, reaching, grasping, lifting, pushing, pulling, and repetitive movements for extended periods. Occasional lifting and moving of materials weighing up to 35 lbs. Ability to wear required PPE and cleanroom garments for extended periods. Manual dexterity and hand/eye coordination for assembly, packaging, equipment operation, and documentation. Visual acuity (with or without corrective lenses) to read handwritten or typed material, adjust focus, and perform visual inspection. Hearing and speech sufficient to communicate on the floor on a continuous basis. Ability to move about the building, maneuver in tight spaces between equipment, and walk on even or uneven surfaces. Ability to work in pharmaceutical manufacturing and packaging areas, including cleanrooms, controlled production areas, and warehouses, where a variety of chemical substances are used, including active pharmaceutical agents and cleaning agents. Duties are performed indoors. Sustained concentration and attention to detail during repetitive assembly, inspection, and documentation tasks. Ability to work flexible schedules, overtime, weekends, or shift work as business needs require. HOW YOUR SUCCESS WILL BE MEASURED Determination of how successful you are is a mix of WHAT you achieve, HOW you achieve it, and how you GROW over time. Your Key Performance Indicators: Within the first 12 months, the GMP Manufacturing Operator will be expected to: Complete and maintain 100% of required training and qualifications for assigned operations. Execute production, packaging, and cleaning activities accurately, with minimal documentation errors requiring correction. Support on-time completion of scheduled production. Maintain an inspection-ready work area and consistent adherence to gowning and contamination control practices. Promptly escalate equipment, process, and quality issues to supervision and Quality Assurance. cGMP requirements Following current Good Manufacturing Practice standards to keep production compliant with FDA/regulatory expectations. Good Documentation Practices (GDP) Recording production activities accurately, legibly, and in real time to support data integrity. Procedure adherence Following batch records, SOPs, and work instructions exactly as written, every time. Catching errors, defects, and discrepancies in materials, product, and documentation before they move forward. Applying gowning, cleaning, and sanitization practices that protect product and controlled environments. Line clearance & reconciliation Verifying lines are clear and that components, labels, and finished goods are fully accounted for. Speaking up promptly about equipment, process, or quality issues and communicating clearly with the team. Teamwork & reliability Showing up consistently and working cooperatively with leads, Quality, and fellow operators. ProMed offers a generous benefits package including: 401k with company match Profit Sharing Program Medical Insurance Health Savings Account/Flexible Spending Account Vision Insurance Life Insurance Paid Family Medical Leave and Long-Term Disability Insurance Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection Pet Insurance ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity. #J-18808-Ljbffr ADP, Inc.