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.

•There are two types of work schedules available for this role, which both operate on a 2-2-3 weekly pattern

•

Daylight:

6:30am-6:45pm

Overnight:

6:30pm-6:45am 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. 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:

$20.15 - $20.90 per hour Expected hours: 40.0 per week

Benefits:

401(k) matching Dental insurance Health insurance Life insurance Paid time off Parental leave Tuition reimbursement Vision insurance Wellness program Application Question(s): Due to the nature of our medical device manufacturing environment, employees working in the certified cleanroom may not wear jewelry, makeup, nail polish, artificial nails, or hair products. The role also requires extensive PPE such as hair/beard net, lab coat, foot coverings, and gloves. Are you comfortable adhering to these requirements as a condition of employment?

Education:

High school or equivalent (Required) Ability to

Commute:

Clinton, PA 15026 (Required)

Work Location:

In person