Quality Assurance Compliance Manager

EO Products•San Rafael, CA

7d•Onsite

About The Position

EO Products is a company with one mission and two brands: to create healthy personal care products that nurture the people who use them, respect the people who make them, and honor the planet we all share. We work hard to ensure our values come to life in each bottle of EO® and Everyone for Every Body® products. We have been family owned, operated, and independent since 1995. We call Northern California home and manufacture our essential oil-based products in-house at our certified organic factory and HQ in San Rafael. You can find us at most of your favorite retailers. We’re a certified B Corp that prioritizes people, planet, purpose, and profit — in that order. We offer a fun casual place to work, great benefits, employee discounts, and free products! We are a diverse team of free-thinking individuals, and our company culture values responsibility, collaboration, integrity and passion. We look forward to hearing from you!

Requirements

Meticulous attention to detail.
Critical Thinking and Problem-Solving Skills.
Excellent interpersonal skills and ability to interact with people at all levels.
Intermediate to advanced computer skills including Word, Excel and electronic QMS.
Oral and written communication skills, with emphasis on training and implementation.
College degree in Chemistry, Biology or Science or equivalent combination of education and experience.
5+ years of experience working in a QA leadership role in manufacturing or related fields.
2+ years of experience managing QA for OTC products.

Nice To Haves

Direct involvement with an OTC production facility is highly preferred.
Knowledge of ISO and FDA Regulations & cGMP in a cosmetic/food environment preferred.

Responsibilities

Directly manage the following for OTC items: Deviations, Non-Conformance, Quality Investigations, Complaints and CAPA’s.
Responsible for the ongoing development of the QMS system to meet and exceed compliance requirements.
Manage internal compliance audits on a recurring basis to ensure adherence to SOP’s.
Responsible for creating FDA Annual Product Reviews (APR) in accordance with FDA standards.
Understand and implement 21 CFR 210/211 for OTC personal care products.
Understand and implement cGMP’s for cosmetic products.
Research and develop action items to address future MOCRA compliance requirements.
Responsible for administering the change management and change control program for OTC products.
In partnership with the Director and Regulatory Department, resolve any open issues related to prior FDA 483’s.
Through ongoing, comprehensive efforts, this role will maintain an “audit ready” status for the Company at all times.
Collaborate with R&D and Product Development to ensure that new products under development can be supported by the QMS.
Conduct ongoing research of trends and developments in quality management & compliance; participating in educational opportunities.
Provide general oversight to quality personnel to help maintain quality processes and ensure compliance to regulations and cGMP.
Work closely with the Regulatory Department to establish a cross-departmental support system for compliance-related requirements.
Identify resource gaps and work with the Director to resolve them in a timely manner.
Responsible for reviewing all SOPs and other document revisions to ensure absence of compliance conflicts.
In partnership with the QA Process Manager, investigate issues that may arise during manufacturing of OTC items: Deviations, Non-Conformance, Quality Investigation and Complaints to identify root cause and determine Corrective Actions Preventive Actions (CAPA) to address root cause.
Develop and maintain compliance training programs and subsequent training records related to the QMS system.
Provide ongoing oversight of testing procedures, specifications and testing methods for each raw material, bulk product & finished good (OTC).
Maintain and ensure completeness and accuracy of OTC batch records.
Regularly develop and generate analytical data from manufacturing, production Quality that can be utilized for early identification and investigation of specification drift.
Perform other reasonable tasks and projects as directed by Management.
Understand and support the EO employee manual, and Standard Operating Procedures.
Must wear lab coat and gloves when working with Essential Oil products, oils, creams, powders or any other related materials as mandated by the Safety Data Sheet.
Must wear mask and/or goggles when working with powders or any other products containing dusts or strong odors or as mandated on the Safety Data Sheet.
Must be familiar with the information given in the Safety Data Sheet and communicate necessary information to staff.
Must use back support belt when lifting or moving any boxed or drums >25 lbs. No lifting over 50 lbs. without assistance.
Must report to the supervisor any unsafe or hazardous condition.