GMP Associate III (Weekend Overnight)

Pay

The pay range for this role is $21.15‑$35.95 per hour. The base pay offered will consider the candidate’s location, education, job knowledge, skills, and relevant experience. Incentives may be provided, including sales commissions for sales roles, discretionary annual bonuses for non‑sales roles, and eligibility for the Company’s long‑term incentive plan (eligibility and target amounts vary by role).

Benefits

• 401(k) plan 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 of vacation annually (based on tenure)
• Accrual of up to 64 hours of paid sick time per year
• Paid and/or floating holidays
• Parental leave
• Short‑ and long‑term disability insurance
• Tuition reimbursement
• Health and welfare benefits
• Potential eligibility for the Company’s long‑term incentive plan

Schedule

Thursday night into Monday morning, 4 × 10‑hour shifts.

Job Summary

The GMP Associate III serves as an area expert across all manufacturing lines, qualified and trained to operate every piece of equipment in the assigned area. This role builds upon the skills of GMP Associate I and II by providing technical leadership, troubleshooting, and guidance to less experienced associates. With a strong focus on safety, quality, and output, the GMP Associate III is the go‑to resource for GMP I and GMP II team members, ensuring production goals are consistently met while maintaining compliance with all GMP, GDP, FDA, ISO 13485, and safety requirements.

Key Responsibilities

• Safety: Act as a role model for safe work practices and PPE adherence; support supervisors in identifying and mitigating safety risks; guide GMP I and II associates on safe equipment operation.
• Quality: Uphold cleanroom discipline, documentation, and GMP compliance; serve as a subject‑matter expert in GDP, reviewing and supporting accurate production and equipment records; perform and verify in‑process inspections to ensure product specifications are met.
• Manufacturing & Delivery: Operate, troubleshoot, and maintain all equipment across the manufacturing area; lead by example in loading/replenishing materials, packaging, and assembly; ensure consistent throughput by proactively resolving technical issues and minimizing downtime; support and oversee TPM (Total Preventive Maintenance) activities.
• Leadership & Mentorship: Provide technical guidance, troubleshooting, and process assistance to GMP I and II associates; deliver informal on‑the‑job training and coaching; collaborate with Production Supervisors, Quality, and Engineering to identify and implement improvements.
• Continuous Improvement: Drive lean initiatives such as 5S, Kaizen, and problem‑solving events; contribute expertise in root‑cause analysis and sustainable solutions; recommend process improvements to enhance safety, efficiency, and product quality.
• Company Values: Embody and reinforce company values; foster teamwork, accountability, and continuous learning; support production leadership in setting a professional, disciplined floor tone; uphold company policies and perform additional duties as needed; communicate effectively with supervisors and team members to resolve issues and ensure smooth production flow.

Qualifications

• High school diploma or equivalent required; technical certification or additional training preferred
• 2–4 years of experience in a GMP‑regulated manufacturing environment (medical device, pharmaceutical, or biotech preferred)
• Fully qualified and trained on all equipment within the manufacturing area
• Strong understanding of GMP, GDP, FDA, and ISO 13485 compliance standards
• Demonstrated ability to troubleshoot and resolve complex equipment and process issues
• Proven track record of mentoring, coaching, or providing guidance to peers
• Excellent attention to detail, problem‑solving, and communication skills
• Comfortable working in a fast‑paced, team‑driven environment

Physical Requirements

• Stand for extended periods and perform repetitive tasks
• Lift/move up to 25 lb as needed
• Wear cleanroom attire (gown, mask, gloves) for prolonged periods