GMP associate l (Overnight)

haemonetics; Pennsylvania; On-site; USD 42,000 - 62,000; Full time

Job summary

Haemonetics in Pennsylvania is seeking a GMP Associate I to support the manufacturing of high-quality medical devices by operating equipment, packing finished products, loading hoppers, and resolving basic equipment faults. The role requires adherence to GMP, GDP, and cleanroom standards, contributing to a safe, lean, and team-oriented environment.

Candidates should be prepared for a 2-2-3 schedule and wear full cleanroom PPE.

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.
• This position operates on a 2-2-3 schedule. 6:30PM-6:45AM

Responsibilities

• Operate production equipment and resolve basic HMI faults.
• Pack finished products and load hoppers to maintain flow.
• Assemble components per work instructions and perform GDP paperwork.
• Adhere to GMP, FDA and ISO 13485 standards in daily tasks.
• Maintain cleanroom protocols and accurate documentation.
• Support lean initiatives and participate in required training.

Skills

Attention to detail

PPE compliance

HMI basic knowledge

Team collaboration

Education

High school diploma or equivalent

Tools

HMI systems

Job description

Job Details

Job Summary

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.

Key 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.
• 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.
• This position operates on a 2-2-3 schedule. 6:30PM-6:45AM

Physical Requirements

• Stand for extended periods; perform repetitive motions.
• Lift/move up to 25 lbs as needed.
• Wear cleanroom attire (gown, mask, gloves) for prolonged periods.

Pay Transparency:

The pay range for this role is:

EEO Policy Statement

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.

Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, 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, and/or health and welfare benefits.

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