Peoplework LLC is hiring for our client, a rapidly growing drug testing organization operating in stealth mode, developing next-generation laboratory testing solutions. We are seeking a Manufacturing Associate to contribute to the commercial production of novel, medical diagnostic devices. You will operate equipment and assemble products in a clean or dry room environment while adhering to strict quality policies and procedures.
Immediate Needs
- Support build‑out and setup of the AC line in H2 and base station line in SR1 (cleaning, staging, construction).
- Complete onboarding and training on core commercial processes (gowning/cleanroom, ESD, traceability, documentation, safety).
- Provide hands‑on production support: kitting, basic assembly, in‑process checks, packaging/labeling, and rework to meet early build schedules.
- Assist receiving and inventory organization: unpacking, labeling, cycle counts, sorting/disposing of legacy inventory, and accurate transactions.
- Perform miscellaneous lab/manufacturing support tasks as assigned (basic measurements, fixture setup, material prep).
Long‑Term Needs
- Execute routine commercial manufacturing across H2, SR1, and TRT, meeting throughput, quality, and documentation requirements.
- Own daily inventory management (receiving support, material moves, cycle counts, Kanban/min‑max restocking) to ensure uninterrupted production.
- Contribute to continuous improvement: propose/implement process and fixture improvements, participate in CAPA/deviation investigations, and support validation/scale‑up.
- Cross‑train across product lines and stations to provide flexible staffing and support future expansion.
Experience
- 2+ years of hands‑on experience in a regulated manufacturing environment (medical device, diagnostics, biotech, or pharmaceutical).
- Experience performing assembly, kitting, labeling/packaging, and basic in‑process inspection activities while meeting production schedules.
- Working knowledge of Good Manufacturing Practices (GMP) and/or Good Documentation Practices (GDP); experience completing batch records, travelers, or device history records (DHR) is a plus.
- Experience working in controlled environments (cleanroom, dry room, ESD‑controlled area) and following gowning, line clearance, and contamination‑control procedures.
- Comfortable using basic hand tools and measurement equipment (e.g., torque drivers, calipers, scales) and following work instructions/SOPs.
Knowledge & Skills
- Proficient in computer systems: Windows, Microsoft Word, Excel, PowerPoint and various file repositories.
- Ability to read and follow detailed instructions, maintain accurate records, and complete product inspections that meet all requirements.
- Understands and adheres to applicable production controls including but not limited to line clearance, gowning, ESD controls, PPE, etc.
- Good communication skills (written and verbal [English]), good penmanship, detail oriented and ability to perform basic arithmetic.
- Understanding basic principles and function of common electronic and mechanical components.
Why Join Us
- Join a confidential, high‑impact drug testing organization
- Play a key role in building manufacturing and validation processes from the ground up
- Work in a collaborative, fast‑paced, and technically challenging environment
- Competitive compensation and benefits
Salary range: $25-$30/hour depending on experience
Due to the confidential nature of our work, additional details will be shared during the interview process.