Quality Assurance Manager
Job brief
The Quality Assurance Manager’s primary responsibilities are to manage the internal lab activities of testing incoming and in-process materials and on-line finished product inspections and analysis. This includes investigating quality defects to root causes and developing corrective actions. This role ensures products meet all quality requirements prior to quality release. As a contributor to the Quality Management System, the Quality Assurance Manager oversees the plant’s GMP and Microbiological standards, performs internal audits, and authors corrective action plans and supplier corrective action requests.
Responsibilities
- Lead, train, and manage the internal quality lab to perform material and microbiological analyses for product release analysis, report, and manage document control systems. Manage external microbiological labs sample processing, reporting, and root cause analysis when required.
- Manage direct reports and the required on-line inspections.
- Develop, implement, and maintain a robust ISO9001:2015 compliant Quality System.
- Understand customer needs and requirements to develop effective quality control processes.
- Develop and update quality risk analysis and quality action plans.
- Develop and update microbiological risk assessment.
- Lead and perform IQ, OQ, and PQ validations.
- Devise and review specifications for products, materials, and processes
- Formulate quality objectives in coordination with production.
- Set requirements for raw material and intermediate products.
- Monitor suppliers’ quality performance and compliance.
- Ensure adherence to health and safety guidelines as well as legal and regulatory obligations applicable to raw materials and finish goods.
- Perform personnel evaluations; provide guidance and feedback.
- Lead and drive quality continuous improvements.
- Investigate root cause and implement corrective actions to customer complaints.
- Perform statistical analysis.
- Interact with plant personnel and sales/customer service personnel on quality problems. Call on customers or potential customers with sales executives to provide assistance relating to quality topics.
Requirements
- Minimum 5 years of proven experience as quality manager in cosmetics, FDA (OTC), and EPA regulated products and processes.
- Minimum 3 years lab experience conducting material and product release testing.
- Knowledge of microbiologically susceptible products and testing procedures.
- Bachelor’s degree in a related or relevant field.
- Certification of quality control is a strong advantage (ISO 9000 etc.)
- Understanding of quality systems and quality tools (ISO, HACCP, SQF, Six-Sigma, etc.).
- Must have excellent organizational skills with ability to complete multiple projects simultaneously in a fast-paced manufacturing environment.
- In depth understanding of quality control procedures and relevant legal/regulatory standards.
- Proven ability to lead, motivate, and direct employees.
- A keen eye for detail and a result driven approach.
- Outstanding communication skills.
- Excellent organizational and leadership skills.
- Proficient in MS Office.
- Excellent math abilities and working knowledge of data analysis/statistical methods.
Job Type: Full-time
Pay: $80,000.00 - $85,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience:
- Quality assurance: 5 years (Preferred)
- FDA regulations: 1 year (Preferred)
- microbiology lab: 1 year (Preferred)
- Cosmetics products manufacturing: 1 year (Preferred)
- ISO 9001: 1 year (Preferred)
- Consumer Goods products manufacturing: 1 year (Preferred)
License/Certification:
- Certified Quality Auditor (Preferred)
Work Location: In person
