Quality Systems Specialist Nomax Inc. - 3.6 St. Louis, MO Job Details Full-time From $24 an hour 7 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Employee assistance program Vision insurance 401(k) matching Employee discount Life insurance Referral program Qualifications High school diploma or GED Attention to detail Quality audits Root cause analysis Associate's degree

Full Job Description Company Overview:

Nomax is a privately held and fast-growing manufacturer of pharmaceuticals, medical devices and dietary supplements located in south St. Louis County. Founded in 1982, Nomax primarily focuses on the manufacture of oral solid dosage products and has become one of the leading manufacturers of effervescent products in the United States.

Position Overview:

Nomax is seeking a Quality Systems Specialist to support our Quality Management System (QMS) and ensure compliance with pharmaceutical and medical device regulations and international quality standards. This role is responsible for maintaining quality records, supporting audits, administering document control activities, and contributing to continuous improvement initiatives. The ideal candidate will bring experience in quality assurance within the medical device, pharmaceutical, or regulated healthcare industry and possess a strong understanding of

ISO 13485, FDA

regulations, CAPA processes, and quality system documentation. The position will be a day shift position and the pay range starts at $24 per hour.

Essential Duties and Responsibilities:

Maintain and process quality records within the electronic Quality Management System (eQMS), including complaints, CAPAs, deviations, nonconformances, and change controls. Ensure records are complete, accurate, and properly routed for review and approval. Compile evidence, timelines, and supporting documentation for investigations. Contribute to root cause analysis and CAPA activities including implementation of CAPA actions. Assist with effectiveness checks and documentation of results. Analyze data accuracy and identify discrepancies for correction. Assist with supplier quality documentation review, SCAR tracking, and audit readiness activities. Support internal and external audit activities. Prepare routine reports and quality data summaries for Quality Systems management.

Qualifications:

Knowledge of Quality Management Systems (QMS) and electronic quality systems (eQMS). Familiarity with 21 CFR Parts 803, 806, 820, 210, and 211. Experienced with technical writing. Excellent effective written and oral communication style for both internal and external communications across department lines. Ability to collaborate with all levels of the Company. Initiative to take on responsibilities and work independently without a high level of oversight. High level of attention to detail, being careful about details in the process and thorough in completing work tasks.

Education/Experience:

High School Diploma or Equivalent. Associates Preferred. 2-4 years of experience in Quality Assurance, Quality Systems, or a related quality function within a regulated industry.

Location:

Onsite at 63123. Nomax is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Type:

Full-time Pay:

From $24.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Tuition reimbursement Vision insurance

Experience:

Quality Assurance:

2 years (Required) Ability to

Commute:

St. Louis, MO 63123 (Required)

Work Location:

In person