GMP Manufacturing Associate II (Weekend Overnights)
Haemonetics
Summary
The cGMP II is a skilled operator position on the weekend floater vacation relief team within Plasma manufacturing operations. Building on the foundation of the cGMP I role, this position performs production tasks while providing support and assistance to the Area Leader to help ensure the team meets production, quality, and safety goals.
Job description
Schedule
- Thursday through Sunday
- 10-hour shifts: 6:30 PM – 4:00 AM
- Highly flexible schedule that may change based on vacation coverage needs
- Frequent changes in assigned areas and job responsibilities
Key Accountabilities
- Demonstrate proficiency on all machinery and processes across Plasma departments
- Perform production tasks accurately, efficiently, and in full compliance with cGMP standards
- Assist the Area Leader with daily coordination, task prioritization, and team support
- Help train and coach cGMP I team members as needed
- Identify and communicate issues, deviations, or opportunities for improvement
- Support a culture of accountability, safety, and continuous improvement
- Remain flexible and adaptable to changing priorities, areas, and work assignments
The GMP Associate II builds on the skills of Associate I by independently operating and troubleshooting manufacturing equipment, maintaining production flow, and ensuring compliance with GMP, GDP, and safety standards. This role also assists with training new associates, supports continuous improvement projects, and contributes to the consistent delivery of safe, effective medical devices.
Key Responsibilities
Safety
- Adhere to PPE and machine operation safety procedures.
- Report hazards, malfunctions, and incidents promptly.
Quality
- Maintain cleanroom standards and enforce gowning compliance.
- Complete and review production records, logs, and maintenance documentation.
- Perform in-process inspections and ensure products meet specifications.
Manufacturing & Delivery
- Load/replenish materials and ensure continuous production flow.
- Assemble components/subassemblies per GMP and work instructions.
- Operate equipment, diagnose and resolve HMI/automation faults, and perform equipment adjustments or troubleshooting.
- Escalate complex technical issues to maintenance/engineering.
- Perform cleaning, sanitization, and equipment care per SOPs.
- Take ownership of Total Preventive Maintenance (TPM) activities to ensure equipment reliability and readiness.
Continuous Improvement & Training
- Actively contributes to process improvements and waste reduction initiatives.
- Support lean practices and problem-solving activities.
- Assist with onboarding and training new associates in GMP practices and equipment operation.
Company Values
- Work cross-functionally with Quality and Engineering to meet/exceed production targets.
- Act as a role model for professionalism and compliance.
- Uphold company policies and procedures, performing additional duties as needed to support production.
- Communicate effectively with supervisors and team members to resolve issues and ensure smooth production flow.
Physical 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.
Requirements
- High school diploma or equivalent.
- 1–2 years of experience in a GMP-regulated manufacturing environment (medical device, pharma, or biotech preferred).
- Strong understanding of GMP/GDP principles.
- Experience with equipment operation and troubleshooting.
- Cleanroom experience preferred.
- Strong teamwork, communication, and attention to detail.
- Basic computer and manufacturing system skills.
Benefits
- 401(k) with employer match
- Employee stock purchase plan
- Paid vacation
- Paid sick time
- Paid holidays
- Parental leave
- Short-term disability insurance
- Long-term disability insurance
- Tuition reimbursement
- Health and welfare benefits
Company overview
Haemonetics Corporation is a global leader in blood and plasma management solutions, founded in 1971 and headquartered in Boston, Massachusetts. As a publicly traded company listed on the NYSE under the symbol HAE, Haemonetics specializes in developing and manufacturing medical devices and systems for blood component collection, processing, and transfusion management. The company operates across three primary segments: plasma collection, blood center operations, and hospital transfusion services. Haemonetics' innovative product portfolio includes automated blood collection systems, surgical blood salvage devices, hemostasis management systems, and temperature regulation equipment for medical applications. With approximately 3,300 employees worldwide and operations in 16 countries, the company generates annual revenues exceeding $1.3 billion. Haemonetics has established itself as a critical partner to healthcare providers by offering comprehensive solutions that enhance patient safety, improve clinical outcomes, and optimize blood management workflows across the continuum of care.