- Duties and Responsibilities:Partners with cross functional team to implement and track Critical to Quality attributes to ensure standards are being adhered to following cGMP.
- Using working knowledge of 21CFR210/211 to drive compliance efforts effectively.
- Ensures compliance with company quality standards and contributes to crafting essential quality protocols and SOPs based on industry benchmarks.
- Communicates quality concerns, highlighting risks and potential impacts on the company's brand reputation, finances, timelines, and overall business objectives.
- Ensures that contract manufacturing facilities uphold standards for product quality, production processes, and equipment maintenance. Engages in assessing and accrediting suppliers and contract manufacturers for quality management.
- Conducts or coordinates audits to ensure adherence to regulations and drives ongoing enhancements.
- Evaluates suppliers for new product initiatives, cost-effectiveness, and business sustainability.
- Reviews Annual Product Reviews and suggests enhancements as needed.
- Establishes, monitors, assesses, and communicates external manufacturer non-conformances and Corrective Action Preventive Action (CAPA) reports, ensuring adherence to set timelines.
- Ensures compliance with company quality standards and contributes to crafting essential quality protocols and SOPs by drawing on industry best practices.
- Communicates quality-related concerns, highlighting their potential risks and impact on the companys brand reputation, financials, schedules, and other business goals.
- Manages additional projects as directed by management.
- Candidate qualifications:Minimum of 5 years of experience in cosmetic and OTC drug Quality and Regulatory Compliance in Beauty and Personal Care. Experience in Skin and Hair Care is required, while experience in Color Cosmetics is desired.
- Bachelors degree in a scientific field such as Chemistry, Microbiology, or Biology is required. Working knowledge ISO 22716; 21CFR 210/211 ; GUI-0001
- Working knowledge of FDA & Health Canada regulations pertaining to OTC and cosmetic manufacture, testing, validation, and documentation
- Experience with managing/interfacing Contract Manufacturers a plus.
- A proven track record of working collaboratively and being accountable.
- A demonstrated passion for the industry, business, company, and/or brand.
- The ability to effectively partner and motivate across functions and with outside vendors.
- The ability to think strategically, creatively, and analytically.
- Outstanding oral and written communication skills.
- Exceptional organizational skills and a great attention to detail.
- Additionally, the ideal candidate would be:Comfortable with and enthusiastic about working in the dynamic work environment.
- Responsible and extremely resourceful in finding answers and solutions when information and data is not readily available.
- Highly self-motivated and directed with the confidence to be able to discern how and when to campion their ideas.
- A conscientious team player with unquestionable personal and professional character and integrity.
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Senior Quality - San Ramon, United States - iTCO Solutions
Description
Onsite in San Ramon
The Opportunity
The Senior Quality & Compliance Analyst is a key member of the Quality team and is responsible for ensuring compliance with quality standards set by the company and Regulatory bodies for cosmetic products, nutritional supplements, and OTC drug products. The person in this role will advise on what those standards are, ensure they are being adhered to, ensure that all required documentation is in place, and managing the software system (Veeva) used to store all Quality and Regulatory related documentation.
Reports to: Sr. Process Development Engineer
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