What are the responsibilities and job description for the Specialist, Quality Assurance position at Shiseido Americas Corporation?
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
You have excellent verbal and written communication skills with the ability to collaborate across the organization
If this sounds like you, we want you on our team. Apply today and let's create something beautiful!
Your Dreams. Our Future .
You may be asked to perform other duties needed to help drive to our vision, fulfill our mission and abide by our organization’s values.
What We Can Offer You
At Shiseido Americas, our pride extends beyond our rich legacy to our passionate and talented team that brings it to life every day. We recognize that without our people, innovation would not be possible. That's why we go above and beyond with our comprehensive benefits program to recognize our employees. With an array of options designed to give our employees peace of mind, our perks & benefits program is more than just a perk – it's an investment in our people's futures. Whether you're looking for comprehensive health coverage, retirement savings, or paid time off, our benefits have you covered! Check out a list of our Benefits and Perks offerings:
The base pay for this position may vary based on geographic location. Actual base pay offered will be based on several factors including job-specific knowledge, education, skills, and depth of experience. In addition to base pay, we may offer additional forms of compensation as components of a total compensation package, including participation in our bonus program which features the ability to overachieve, in addition to a full range of competitive benefits.
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
You have excellent verbal and written communication skills with the ability to collaborate across the organization
If this sounds like you, we want you on our team. Apply today and let's create something beautiful!
Your Dreams. Our Future .
You may be asked to perform other duties needed to help drive to our vision, fulfill our mission and abide by our organization’s values.
What We Can Offer You
At Shiseido Americas, our pride extends beyond our rich legacy to our passionate and talented team that brings it to life every day. We recognize that without our people, innovation would not be possible. That's why we go above and beyond with our comprehensive benefits program to recognize our employees. With an array of options designed to give our employees peace of mind, our perks & benefits program is more than just a perk – it's an investment in our people's futures. Whether you're looking for comprehensive health coverage, retirement savings, or paid time off, our benefits have you covered! Check out a list of our Benefits and Perks offerings:
- Medical, Dental, & Vision Insurance
- Life and Disability Insurance
- Paid Time Off
- Paid Volunteer Days
- Paid Company Holidays
- Paid Parental Leave
- 401K with 6% Company Match
- Talent Development & Learning Programs
- Internal & International Mobility
- Product Discounts & Annual Gratis
- Employee Led Affinity Groups
- Tuition Reimbursement
The base pay for this position may vary based on geographic location. Actual base pay offered will be based on several factors including job-specific knowledge, education, skills, and depth of experience. In addition to base pay, we may offer additional forms of compensation as components of a total compensation package, including participation in our bonus program which features the ability to overachieve, in addition to a full range of competitive benefits.
