- 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 company's 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.
- Bachelor's 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.
-
Senior Quality
3 weeks ago
Rodan & Fields, LLC San Ramon, United StatesThe Senior Quality & Compliance Analyst is a key member of the Quality team and is responsible for ensuring compliance with quality standards set by Rodan Fields and Regulatory bodies for cosmetic products, nutritional supplements, and OTC drug produ Compliance Analyst, Quality, ...
-
Senior Quality
3 weeks ago
iTCO Solutions San Ramon, United StatesOnsite 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 ...
-
Senior Quality
2 weeks ago
iTCO Solutions San Ramon, United StatesOnsite 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 ...
-
Senior Quality Engineer
5 days ago
Hitachi Careers Alamo, United StatesDescription · Hitachi Energy is seeking for a Senior Quality Engineer for its Alamo, TN Location. · Your Responsibilities: · Design, analyze and evaluate quality assurance systems. Act as principal investigator on Company sponsored task forces and organize and direct technical e ...
-
Senior Quality Engineer
2 weeks ago
10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
-
Senior Quality Engineer
3 weeks ago
10X Genomics Pleasanton, United States10x is seeking a · Senior Quality Engineer, · who will be a member of the · Global Quality organization , reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analy ...
-
Senior Quality Engineer
1 week ago
10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
-
Senior Quality Engineer
1 week ago
10X Genomics Pleasanton, United States10x is seeking a · Senior Quality Engineer, · who will be a member of the · Global Quality organization , reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analy ...
-
Senior Quality Engineer
2 weeks ago
10X Genomics Pleasanton, United States10x is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization, reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analyzing and r ...
-
Senior Quality Engineer
2 weeks ago
10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
-
Senior Quality Engineer
3 weeks ago
10X Genomics Pleasanton, United States10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
-
Senior Quality Engineer
3 days ago
JobRialto San Leandro, United StatesRequired Skills · 1) 5+ years of experience in Java · 2) 5+ years of Test Automation Experience - Selenium, BDD, Cucumber · 3) Good understanding of Service Virtualization and its need/purpose (Hands-on will be a plus) · 4) 5+ years of SOAP/Rest API testing and automation. · ...
-
Senior Director, Quality
1 week ago
Stanford Health Care Emeryville, United StatesIf you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. · Day - 08 Hour (United States of America) · Senior Director, Quality - Cancer DSL · Location: Pal ...
-
Senior Quality Engineer
3 days ago
Flexton San Francisco, United StatesJob TITLE: · Senior Quality Engineer · Location: · San Francisco CA · Term: · Contract to Hire · Skill: As part of the QE function, the overall focus of the group is on competitive market and customer requirements, technology advances, product quality, product cost and time-to ...
-
Senior Quality Engineer
4 weeks ago
Universal Scientific Industrial Co., Ltd. Fremont, United StatesUSI/Asteelflash is actively looking for a Senior Quality Engineer to join our Quality Team here in Fremont, CA. · The successful candidate will be responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of qualit ...
-
Senior Quality Assurance
1 week ago
Revolution Medicines, Inc. Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic varian ...
-
Senior Quality Engineer
1 week ago
MASS Precision, Inc. Fremont, United States**This is not for software engineers** · **Manufacturing Quality Engineers ONLY** · About Us: · MASS provides a comprehensive suite of cost-effective services, encompassing design and engineering, precision sheet metal fabrication, precision machining, painting, and metal finishi ...
-
Senior Quality Engineer
2 weeks ago
Universal Scientific Industrial Co., Ltd. Fremont, United StatesUSI/Asteelflash is actively looking for a · Senior Quality Engineer · to join our Quality Team here in Fremont, CA. · The successful candidate will be responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of ...
-
Senior Quality Technician
2 weeks ago
Randstad Life Sciences US Menlo Park, United StatesExciting opportunity for a Senior Quality Technician to work with a growing biotechnology company focused on cancer screening and detection. · Primary responsibilities include completing required document reviews and material inspections, completing associated forms and other doc ...
-
Senior Quality Engineer
3 weeks ago
Online Technical Services Fremont, United StatesJob DescriptionJob Description · Senior Quality Engineer - Medical · Company Overview: · We are a privately held, fast-paced medical device company located in Fremont, CA that is developing a greatly simplified glucose monitoring system for people with diabetes. The Company's ...
Senior Quality - San Ramon, United States - ITCO Solutions, Inc.
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
Senior Quality professionals in San Ramon
-
Eshaa Venkatesh
Senior Industrial Designer & CMF Design Lead