Quality Systems Coordinator - cGMP & Audits (On-Site)

Ortho Molecular Products; Town of Wausau (WI); On-site; USD 33,000 - 39,000; Full time

Benefits offered by this job

Bonus Program

Health Insurance

HSA

Dental Insurance

Vision Insurance

Short-Term Disability

Life Insurance

401(k) Plan

Health Savings Account

Paid Time Off

Paid Holidays

On-Site Wellness Meals

Gym Membership Reimbursement

Employee Assistance Program (EAP)

Voluntary Benefits

Tuition reimbursement

On-Staff Health Coach

Wellness initiatives

Job summary

Ortho Molecular Products is seeking a Quality Systems Coordinator to support the development, maintenance, and improvement of our quality management system at our Stevens Point, WI facility. The role runs Monday through Friday, 8:00 a.m.

to 5:00 p.m., and focuses on cGMP compliance, SOP management, and audits. The ideal candidate will have a BS/BA in a related field (or 1–3 years of experience), basic GMP knowledge, and may benefit from PCQI or Food Safety certifications.

Qualifications

• BS/BA degree preferred but not required and/or 1-3 related experience.
• Basic Knowledge of Good Manufacturing Practices desired.
• Certifications PCQI or Food Safety and/or relevant professional experience are an asset.
• Ability to maintain confidentiality and professionalism including a high standard of diplomacy.
• Detail-oriented, organized approach with the ability to manage multiple prioritizes.

Responsibilities

• Review, understand, and apply regulations to related dietary supplement Good Manufacturing Practices (cGMPs).
• Assist in creating and revising controlled documents such as Standard Operating Procedures (SOPs).
• Gather information to facilitate the revision of quality programs and technical documents.
• Assist with data collection and operational support for investigations and root cause analysis.
• Plan, initiate or execute desktop supplier and program audits.
• Provide background support to regulatory and third‑party certification audits.
• Generate existing reports related to assigned quality programs.
• Relay department and program inquiries and requests.

Skills

BS/BA degree

GMP knowledge

PCQI certification (asset)

Confidentiality & professionalism

Detail-oriented & organized

Education

BS/BA degree in related science/business

Job description

Ortho Molecular Products is seeking a Quality Systems Coordinator to support the development, maintenance, and improvement of our quality management system at our Stevens Point, WI facility. The role runs Monday through Friday, 8:00 a.m.

to 5:00 p.m., and focuses on cGMP compliance, SOP management, and audits. The ideal candidate will have a BS/BA in a related field (or 1–3 years of experience), basic GMP knowledge, and may benefit from PCQI or Food Safety certifications.