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 primary responsibility of the QA Specialist is to review Batch records, specifications, procedures, protocols, and records for GMP compliance, and the Release of Finished Goods (OTC).  Also responsible for supporting GMP audits (interna/external) and conducting Annual Product Review of OTC products.

 

WHAT YOU WILL DO  

• Perform compliance review of Production batch and control records for OTC products and initiate investigations for any unexplained discrepancies found.
• Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
• Support non-conformance and deviation investigations
• Accurately file and maintain batch production and control records for OTC products.
• Conduct Annual Product Review of OTC products.
• Support internal and external quality audits, reporting observations and concerns to the appropriate parties through verbal presentation and written audit reports.
• Provide GMP Training to other departments as needed
• Research and prepare data needed for monthly quality metrics reporting

 

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
• You have experience working in SAP 
• You are an expert in Excel and PowerPoint presentation preparation
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