Quality Systems Coordinator — cGMP & Audit Focus

Ortho Molecular Products; Stevens Point (WI); On-site; USD 33,000 - 39,000; Full time

Benefits offered by this job

Bonus Program

Health, HSA, Dental, Vision Insurance

Short-Term Disability

Life Insurance

401(k) Plan

Health Savings Account (HSA)

Paid Time Off

Paid Holidays

On-Site Wellness Meals

Gym Membership Reimbursement

EAP

Voluntary Benefits

Growth and Development Opportunities

On-Staff Health Coach

Health and Wellness Initiatives

Job summary

Ortho Molecular Products seeks a Quality Systems Coordinator at our Stevens Point, Wisconsin facility to support our quality management system’s development and continuous improvement. The role is full-time and on-site, with standard business hours, contributing to cGMP compliance and documentation control.

Ideal candidates will have a BS/BA in a related field or 1–3 years of related experience, with knowledge of cGMPs and related certifications viewed as an asset.

Qualifications

• BS/BA preferred but not required; 1-3 related experience accepted.
• Basic knowledge of Good Manufacturing Practices (cGMPs) desired.
• Certifications PCQI or Food Safety are a plus.
• Ability to maintain confidentiality and professionalism with diplomacy.
• Detail-oriented, organized, able to manage multiple priorities.

Responsibilities

• Review, understand, and apply regulations to dietary supplement cGMPs.
• Assist in creating and revising SOPs.
• Gather information to revise quality programs and technical documents.
• Assist with data collection and investigations and root cause analyses.
• Plan or execute desktop supplier and program audits.
• Provide support for regulatory and third-party certification audits.
• Generate reports related to assigned quality programs.
• Relay department inquiries and requests.

Skills

Quality systems

Regulatory compliance

Documentation control

Attention to detail

Education

BS/BA in related science/business field

Job description

Ortho Molecular Products seeks a Quality Systems Coordinator at our Stevens Point, Wisconsin facility to support our quality management system’s development and continuous improvement. The role is full-time and on-site, with standard business hours, contributing to cGMP compliance and documentation control.

Ideal candidates will have a BS/BA in a related field or 1–3 years of related experience, with knowledge of cGMPs and related certifications viewed as an asset.