What you’ll do:
- Develop effective quality control processes.
- Devise and review specifications for products or processes.
- Establish requirements for raw material or intermediate products for suppliers.
- Manage Ro’s contractual obligations under product quality agreements
- Develop and maintain a quality document management system
- Coordinate with contract manufacturers and internal teams to gather raw material and finished product documentation and analyze its validity.
- Participate in CMO audits, as necessary, including preparation of audit plans and documentation of post-audit findings.
- Contribute to regulatory submissions such as product registrations and record requests.
- Responsible for keeping up with and understanding the regulatory environment and quality requirements for dietary supplements, personal care products, and OTC medications.
What You Bring to the Team:
- Bachelor's degree (BA or BS) required.
- 2-5 years of FDA-regulated product industry experience, including 2-4 years in a Quality Audit role.
- Knowledge of the regulatory landscape for the labeling and manufacturing of various FDA regulated products including dietary supplements, prescription and OTC monograph drugs, and personal care products.
- Knowledge of safety reporting requirements for FDA-regulated products.
- Must be able to innovate, analyze, and solve problems with minimal supervisory input.
- Excellent communications, listening, and negotiation skills are necessary.
- Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
- Must have outstanding attention to details.
Benefits + Perks:
- Full medical, dental, and vision insurance + OneMedical membership
- Healthcare and Dependent Care FSA
- Commuter benefits
- Unlimited PTO
- Fitness reimbursement
- Paid maternity/parental leave