What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Continental Manufacturing?
We are seeking a skilled and detail-oriented Senior Quality Assurance Specialist to join our team. As a key player in ensuring the highest quality standards and regulatory compliance (FDA & EPA), you will oversee the batch record review and release process for our personal care products. You will also manage Standard Operating Procedures (SOPs) and contribute to maintaining our quality management system.
Key Responsibilities:
- Oversee the batch record review and product release process, ensuring all products meet quality standards.
- Ensure compliance with FDA regulations, ISO standards, and customer-specific requirements.
- Participate in customer and government agency audits.
- Manage and maintain Standard Operating Procedures (SOPs).
- Support continuous improvement efforts within the quality management system.
- Collaborate cross-functionally to address quality-related concerns and implement corrective and preventive actions (CAPA).
- Train staff on quality assurance processes, SOPs, and regulatory requirements.
- Assist in preparing for regulatory inspections and audits.
- Maintain accurate quality assurance records and generate reports for management review.
Qualifications:
- Bachelor’s degree in Chemistry, Chemical Engineering, or a related field; relevant certifications preferred.
- Minimum of 2 years of FDA experience, with expertise in Over-the-Counter (OTC) products and ISO standards.
- Strong technical writing skills.
- Bilingual candidates (English/Spanish) preferred.
- Proficiency in quality management systems and Microsoft Office products (Excel, Word, Outlook).
- Strong knowledge of batch record review, GMP compliance, and SOP management.
- Excellent attention to detail, analytical skills, and communication abilities.
Why Join Us?
Be part of a growing contract manufacturing company focused on delivering quality products that make a difference. We offer a collaborative and fast-paced work environment where you can develop your skills while playing a critical role in ensuring our products' success.
How to Apply:
If you meet the qualifications and are excited about this opportunity, please click apply.
We look forward to hearing from you!
Salary : $65,000
