Overview:
The Quality Assurance Manager helps oversee the overall quality of products within our FDA-registered manufacturing facility and manages the company Quality System. This role involves ensuring compliance with FDA regulatory requirements 21 CFR part 210 and 211, company standards and industry best practices. The QA manager collaborates with cross-functional teams to enhance product quality, manage deviations/CAPA's, implement validation protocols, manage SOP’s and drive continuous improvement.
Responsibilities:
Quality Management:
- Company quality system remediation.
- Develop and implement quality assurance policies, procedures, SOP’s and guidelines.
- Monitor operations that impact product quality, from raw material receipt to finished goods.
- Conduct regular equipment and process calibration.
- Conduct regular quality assessments and audits to identify areas for improvement.
- Collaborate with production teams to address quality-related issues promptly.
- Develop and implement quality agreements with suppliers and clients.
Regulatory Compliance:
- Ensure compliance with FDA regulations 21 CFR part 210 and 211, cGMP (Current Good Manufacturing Practices), and other relevant standards.
- Stay informed about industry trends, changes in regulations, and emerging quality practices.
- Partner with the plant leadership team to ensure buy-in and commitment to quality assurance.
Quality Control and Testing:
- Oversee product testing, including raw materials, in-process samples, and finished goods.
- Analyze quality data, identify trends, and recommend corrective actions.
- Manage the release of products based on established quality criteria.
Documentation and Reporting:
- Maintain accurate and complete quality records, including batch records, test results, change control logs, equipment calibrations and deviations.
- Prepare quality reports and communicate findings to relevant stakeholders.
- Ensure timely closure of corrective and preventive actions (CAPAs).
Supplier Quality Management:
- Work closely with suppliers to ensure the quality of incoming materials.
- Conduct supplier audits and assessments.
- Collaborate on supplier corrective actions when necessary.
Training and Development:
- Train employees on quality procedures, standards, and safety protocols.
- Foster a culture of quality awareness and continuous improvement.
Product Complaints and Investigations:
- Investigate customer complaints related to product quality.
- Implement corrective actions to prevent recurrence.
Risk Management:
- Identify and assess quality risks within the manufacturing process.
- Mitigate risks through effective quality control measures.
Qualifications:
- Degree, experience and/or certifications in a relevant field.
- Proven experience in quality assurance or quality control within a manufacturing environment.
- Knowledge of FDA 21 CFR part 210 and 211 regulations, cGMP, and ISO quality standards.
- Excellent analytical skills and attention to detail.
- Effective communication and leadership abilities.
Job Types: Full-time, Part-time
Pay: $25.00 - $28.00 per hour
Benefits:
Experience:
- Quality assurance: 2 years (Required)
- FDA regulations: 2 years (Required)
- Quality systems: 1 year (Required)
Ability to Commute:
- Cincinnati, OH 45237 (Required)
Ability to Relocate:
- Cincinnati, OH 45237: Relocate before starting work (Required)
Work Location: In person
