Summary:

We are searching for a Sr. Regulatory Affairs and Quality Assurance Specialist to support our QA and R&D Department. This role will be responsible for inspecting and testing products throughout the production process and maintain the official record for all product registrations and support the Regulatory Associates in maintaining regulatory approvals.

Primary Position Responsibilities:

• Direct support for the QA Manager in problem identification, evaluation, resolution, and continuous improvement.
• Maintain all necessary regulatory registrations, approvals, and certifications to facilitate the sales of products in each regulatory market, including Europe and other countries as determined by company's goal.
• Participate in product development activities ensuring local regulatory standards are understood and implemented to support regulatory submissions.
• Assist in inspecting and manually testing products before, during, and after the manufacturing process to ensure standards are met.
• Perform root-cause analysis and other problem-solving activities to identify corrective actions.
• Execute assigned tasks on schedule according to standard operating procedures and supervisor instructions.
• Maintain accurate records and documents within internal system.
• Constantly assess quality issues and support identified strategies and solutions.
• Communicate and work effectively across departments (R&D, Sales, Production) for the proper execution of quality products.
• Assist in Audit coordination for ISO 22716, Cosmetics Good Manufacturing Practices.
• Maintain accurate tracking and trending of all customer complaints and defective products.
• Assist in investigations for manufacturing/laboratory deviations and customer complaints.
• Compile documents and samples for Annual Product Testing.
• Assist with regulatory compliance matters as needed.

Required Skills:

• Requires Bachelor's degree (BS) in Chemistry, Engineering, or a related field.
• 5+ years experience in a Quality Department/ Regulatory Affairs with GMP training. cGMP preferred
• Experience in the cosmetic industry within a regulatory or QA department is a plus.
• Experience with GC is a plus.
• Requires knowledge of EU and global registration and submission requirements
• Excellent written, verbal and communication skills with ability to write and edit technical documentation.
• Strong computer skills with working knowledge of MS Office, especially Word and Excel
• Ability to manage multiple tasks simultaneously & prioritize work activities working both independently and in a team environment.