GMP associate l (Overnight)
Haemonetics · Clinton, PA · 3 wk ago
OTHRFull-time
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, Haemonetics is your employer of choice.
About the role
The GMP Associate I supports the manufacturing of high-quality medical devices by operating equipment, packing finished products, loading automatic hoppers, and resolving basic equipment faults through HMI (Human-Machine Interface) screens. This role requires adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and cleanroom standards while contributing to a safe, lean, and team-oriented environment.
Responsibilities
- Safety
- Follow all safety procedures, including the proper use of PPE.
- Report hazards, malfunctions, and incidents promptly.
- Quality
- Adhere to cleanroom protocols and gowning requirements.
- Maintain accurate, compliant documentation (batch records, logs, GDP).
- Perform in-process checks and follow GMP, FDA, and ISO 13485 standards.
- Manufacturing & Delivery
- Load hoppers and monitor material levels to avoid interruptions.
- Assemble components and subassemblies per work instructions.
- Execute activities in molding such as proper packaging and completion of GDP paperwork.
- Operate production equipment and resolve basic HMI faults, escalating as needed.
- Perform routine cleaning and sanitization of equipment and workspace.
- Continuous Improvement
- Participate in lean initiatives (5S, Kaizen, QEK).
- Complete required lean curriculum for associate level.
- Company Values
- Collaborate with Quality, Engineering, and other teams to achieve production goals.
- Uphold company values and policies with professionalism.
Requirements
- Stand for extended periods; perform repetitive tasks.
- Lift/move up to 25 lbs as needed.
- Wear cleanroom attire (gown, mask, gloves) for prolonged periods.
Qualifications
- High school diploma or equivalent.
- Prior manufacturing or production experience preferred.
- Basic knowledge of HMI systems and cleanroom procedures a plus.
- Strong attention to detail and commitment to quality.
- Ability to stand for long periods and perform repetitive tasks.
- Willingness to wear full cleanroom PPE.
Schedule
This position operates on a 2-2-3 schedule: 6:30 PM – 6:45 AM.
Benefits
- 401(k) with up to a 6% employer match and no vesting period.
- Employee stock purchase plan.
- “Flexible time off” for salaried employees; for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure).
- Accrual of up to 64 hours (annually) of paid sick time.
- Paid and/or floating holidays, parental leave.
- Short- and long-term disability insurance.
- Tuition reimbursement.
- Health and welfare benefits.