What are the responsibilities and job description for the Quality Assurance Manager position at Spectrum Chemical?
Job Summary
We are seeking a dynamic Quality Assurance Manager to join our team and play a key role in developing and leading our Quality department. As part of Spectrums operations, you will oversee critical Quality Assurance functions, ensuring compliance with regulatory agencies such as the FDA, EPA, DEA, and more. You will collaborate with cross-functional teams and help build a strong Quality team that drives operational excellence.
Key Responsibilities
- Lead the sites Quality Assurance operations, fostering team development and operational efficiency.
- Partner with cross-functional teams, including Operations and Quality Control, providing advisory support to management and team members.
- Ensure compliance with cGMPs, ISO 9001 standards, and other applicable regulations.
- Serve as the subject matter expert on FDA regulations and requirements, acting as the liaison for regulatory agencies.
- Manage readiness and execution for audits and inspections conducted by customers, suppliers, or regulatory agencies.
- Oversee the investigation and resolution of Out of Specification (OOS) reports, product / process deviations, and customer complaints.
- Participate in qualifying suppliers / vendors and support Supply Chain Management initiatives.
- Negotiate and maintain Quality Agreements with vendors and partners.
- Develop and deliver GMP, ISO, and GDP training programs.
- Oversee and maintain the ISO 9001 certification process.
- Author, review, and update Standard Operating Procedures.
- Drive problem-solving initiatives to resolve quality issues while adhering to project timelines.
- Collect and analyze quality data, determining corrective actions to promote safety, quality, and efficiency.
- Identify and implement process improvement opportunities in quality, cost, and performance.
Qualifications
Education and Experience :
Communication / Language Skills :
Preferred Certifications :
Why Join Us?
At Spectrum, we are committed to fostering a collaborative and innovative environment where you can thrive professionally. Join our mission to uphold the highest standards in pharmaceutical quality while making a meaningful impact in a critical industry.