What are the responsibilities and job description for the Quality Systems Specialist position at Amcon Laboratories Inc.?
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.
SUMMARY
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’s main responsibilities include execution of the QMS, audit program, investigation 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Executes the electronic Quality Management System (eQMS) workflows (CAPAs, deviations, nonconformances, and change control) by managing workflows from initiation to approval.
- Documents investigates, and proposes actions on issues documented as a deviation, out of specification result, or supplier fault via root cause analysis tools and operator interviews to determine corrective action.
- Supports Corrective and Preventive Action (CAPA) investigations, to determine root cause (s), define actions, and determine adequate effectiveness checks.
- Executes audits to determine compliance with internal procedures and applicable regulation. Creates audit report for reviewal and approval.
- Applies change control and validation processes via documented procedures.
- Implements the supplier approval process by defining supplier classification, creation of supplier file, and submitting quality agreements.
- Executes data analytics on key processes (Annual Product Reviews, Complaints, Management Review, etc.) to include the creation/execution of presentation, documenting follow-up actions, and submitting final report for review and approval.
- Present quality topics training, review adequacy of training, and update training files.
- Must be able to lift up to 40 pounds and have the ability to move frequently throughout the building.
- No travel or non-standard work hours are required.
- Temperature controlled work environment.
QUALIFICATIONS
- Knowledge of Quality Management Systems (QMS) and electronic quality systems (eQMS).
- Familiarity with 21 CFR Parts 803, 806, 820, 210, and 211.
- Technical writing experience.
- 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 AND/OR EXPERIENCE
- Minimum Required: High School diploma.
- Minimum Required: 3 years of experience in Quality Assurance, Quality Systems, or a related quality function within a regulated industry.
LICENSES AND CREDENTIALS
- Minimum Required: None
SYSTEMS AND TECHNOLOGY
- Proficient in Microsoft Excel, Word, PowerPoint, Outlook
Pay: $24.00 - $28.00 per hour
Expected hours: 40.0 per week
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
Work Location: In person
Salary : $24 - $28