Quality Manager
Classic Westchester
- Waterbury, CT
- $85,000-100,000 per year
- Permanent
- Full-time
- Develop, implement, and monitor aspects of site Quality Management System, including, but not limited to:
- Communicate product issues and deviations to clients, when required
- Ensure a high level of internal and external customer service by responding to customer needs in a timely manner
- Respond to CAPAs (site, supplier quality, safety, audits, etc) as assigned
- Revise or create standard operating procedures
- Establish quality standards, objectives, and goals and communicate to site personnel
- Participate in and provide information for regular Quality Management Review Meeting discussions
- Approval of specifications, sampling instructions, and test methods
- Promote quality achievement and performance improvement across the organization
- Respond to or coordinate response to any out of specification reports related to site product
- Ensure compliance with all applicable regulations and requirements
- Write, review, and/or approve site validation protocols and summary reports
- Perform internal and supplier audits as required
- Prepare reports and data related to departmental objectives or requirements (such as APR)
- Oversee hourly quality personnel (scheduling, performance reviews, disciplinary action, hiring & firing)
- Self-starter
- Positive attitude
- Able to work in fast-paced environment
- Ability to generate and comprehend technical/analytical reports
- In-depth knowledge of the regulatory environment for manufacture of OTC/FS.
- Capable to manage tasks in matrix and ability to interact successfully with multi-functions globally and regionally
- Strong analytical, problem solving, and decision-making skills
- Excellent verbal and written communication skills
- Success working with multifunctional, regional and global teams
- Excellent communication/negotiation skills required
- Extensive working knowledge of applicable quality and regulatory standards and regulations
- Experience in risk management, validation, analytics and microbiology, within a GMP environment
- Must be certified in food safety (SQF, HACCP, or equivalent)
- Domestic travel (<10%)
- Experience managing others
- Able to sit/stand for periods lasting 2 hours or more
- Able to work in unconditioned environments {both hot and cold)
- Must be able to wear company issued protective equipment