Associate Specialist, Quality Assurance

Your Dreams, Our Future.

 

Join the dynamic and diverse team at Shiseido Americas, a subsidiary of the world-renowned Shiseido Company Limited. Be a part of a portfolio of prestige beauty brands which includes Clé de Peau Beauté, Drunk Elephant, Dr. Dennis Gross Skincare, NARS, SHISEIDO and several prestige fragrance brands including Issey Miyake, Narciso Rodriguez and Tory Burch. At Shiseido Americas we value and celebrate human diversity, with a rich tapestry of employees from all backgrounds and experiences.

 

Headquartered in New York City with US offices and facilities located in New Jersey, Ohio, Texas and Florida, Shiseido Americas employs over 2,000 individuals in the US, Canada, and Latin America. Shiseido Americas is a hub of talent and innovation. Be inspired by the array of skills, knowledge, and integrity of your colleagues, and join our driving force as Shiseido continues its pursuit of beauty innovations for a better world.

 

At Shiseido Americas, we focus on our people. We strive to foster a collaborative workplace culture where creative thinking, inclusivity and unique diverse perspectives are celebrated in order to drive success for both our employees and the company as a whole. By prioritizing our team and promoting an open-minded environment, we push the boundaries of what's possible and bring new ideas to life.

 

Without compromising our steadfast commitment to Quality, Safety and Sustainability our manufacturing and packaging facility produces in excess of 70MM units per year.   This is a demonstration of our can-do attitude, collaborative spirit, focus on innovation and continuous improvement mindset.���  Always People First!  

JOB SUMMARY 

The Associate Specialist, Quality Assurance is responsible to prepare and complete the CARES act report for the FDA, BOM review and approval, Bulk and Finished Good,  releasing Finished Goods (OTC, Non-OTC etc.), reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance. 

 

WHAT YOU WILL DO  

• Prepare and complete the CARESS ACT list for FDA.
• BOM review and approval, set up the system specifications for Finished Goods, FG, Bulk work closely with different departments
• Responsible for Releasing Finished Goods (OTC, Non-OTC etc.)
• Prepare master production records for all OTC products.
• Review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
• Perform review of Production batch records and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
• Provide assistance in Investigation as required.
• File and maintain batch production and control records for OTC product.
• Conduct/review Annual Product Review of OTC products.  Record the observations that needs follow up with AIC team.
• Provide GMP Training to other departments as needed
• Research and prepares data needed for monthly quality metrics reporting
• Assist in any project/task assigned by the Manager.

 

WHO YOU ARE

• You hold a Bachelors' degree (B.A.), preferably in an Engineering or Science discipline from a 4-year college or university. 
• You have a minimum of two years' experience working in an FDA regulated industry with strong knowledge of Pharmaceutical GMP documentation requirements
• You have a solid understanding of 21CFR (Part210-211), ICH guidelines