Quality Assurance & Regulatory Affairs Assistant/Technician

About Good Clean Love

Woman owned and led, we are revolutionizing vaginal health and self-care. Good Clean Love is the #1 Natural lubricant in the market, and we continue to expand into overall vaginal health. We are also an Inc. 5000 listed ‘fast growing’ company.

There are many common health challenges that women face that are poorly served by the current market. We are comprised of three interrelated organizations: Good Clean Love, The Sexual Health & Wellness Institute (SHWI), and Vaginal Biome Science. Through the ecosystem of these organizations, we are leading research-based and data-based solutions to common conditions experienced by women and bringing those direct to the consumer as well as through our Professional Program. This role supports the quality/regulatory efforts across our consumer and biotechnology programs.

Qualifications

· Associate or bachelor’s degree, preferably in a science or legal discipline OR an equivalent combination of certificates and experience

· 3 years’ experience in a regulated environment OR demonstrated willingness to learn

o Examples: 21 CFR 820, 111, 211, ISO 13485, ISO 9001, SQF (or other food quality management systems)

· General knowledge of manufacturing processes

· MoCRA/FDA/CDER/Health Canada portal experience a plus

· Demonstrated effective verbal and written communication skills

· Data/filing management & word processing (Microsoft Office Suite)

· High attention to detail

· Demonstrated ability to work independently, following defined procedures

· Ability to exercise discretion and sound judgment

· Strong organizational and problem-solving skills

· Ability to lift <25lbs

Responsibilities

· Administrative and Quality Management System support to the Quality & Regulatory Manager, working closely on recurring regulated documentation management, and supporting as needed on larger scale projects and research

· Recurring regulated documentation may include:

§ Vendor documentation

§ Employee training documentation

§ Product registrations

§ SDS maintenance

§ Customer complaint investigation and tracking

§ Assist with CAPA implementation

§ 510k submissions and updates

§ Controlled document development and risk analysis

§ Participate in the preparation of management review data and presentations

§ Assist QA/RA Manager in audits and certifications

§ Other recurring tasks as needed

Ability to identify quality areas for improvement and assist in implementation

· Database maintenance – document test results, incoming and outgoing retention samples, etc.

· Ensure compliance with all applicable laws and regulations, as well as company standards and specifications.

Part time up to 20 hours per week with potential to increase to full time.

Good Clean Love jobs

Quality/Regulatory Assistant