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.

WHERE YOU WILL WORK

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 Specialist, Quality Assurance, is responsible for the review and approval of Bills of Materials (BOMs) of Bulk and Finished Goods. This position oversees the release of both OTC and Non-OTC Finished Goods, and conducts thorough reviews of batch records, specifications, procedures, protocols, and related documentation to ensure compliance with Good Manufacturing Practices (GMP). Additional duties include supporting both internal and external GMP audits. The role encompasses a broad spectrum of quality assurance functions that affect product release, regulatory adherence, and coordination with regional QA teams. The ideal candidate demonstrates advanced technical knowledge, enhanced decision-making authority, and a comprehensive understanding of quality systems.

WHAT YOU WILL DO

• You will be responsible for the review and approval of Bills of Materials (BOMs), which directly impacts product composition, labeling accuracy, and regulatory compliance.
• You will be responsible for releasing and controlling non-conforming finished goods (FG) holds, including evaluating supporting data, coordinating with QA and production, and documenting final disposition decisions.
• You will be responsible for updating data for the S&OP Team and addressing queries related to releases.
• You will collaborate with other regions’ QA teams regarding Certificates of Analysis (CoAs), including investigation of discrepancies, clarification of test results, and resolution of documentation issues.

• You will review and follow up on production discrepancies identified in batch records or associated documentation, ensuring timely closure and proper root cause documentation. Support the investigations as required.

• You will apply quality principles, technical evaluation, and cross-functional judgment related to product release and GMP compliance.
• You will prepare master production records for all OTC products.
• You will be responsible for reviewing raw materials, packaging materials, in-process materials, and finished product specifications to ensure GMP compliance, including the reconciliation of OTC batch records.
• You will be responsible for reviewing production batch records and control records for OTC products, initiating investigations into any unexplained discrepancies identified during this process. Additionally, you will prepare Certificates of Manufacturing and Compliance and oversee the release of OTC products for shipment.
• You will file and maintain batch production and control records for OTC product.
• You will conduct/review the Annual Product Review of OTC products.
• You will responsible for preparing the annual CARES Act product list, to submit to FDA.
• You will assist in Internal/External Quality Audits, report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
• You will assist in the change request process.
• You will be responsible to prepare the Product destruction list and collecting the proof of destruction.
• You will provide GMP Training to other departments as needed
• You will research and prepare data as needed for monthly quality metrics reporting
• You will assist with any project/task assigned by the Manager.

WHO YOU ARE

• You have a bachelor’s degree (B. A.) from four-year college or university, preferably with a Engineering or Science major.
• You have three years’ knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
• You have a good understanding of 21CFR (Part210-211), ICH guidelines
• You have experience with SAP systems
• You are an expert in Excel and PowerPoint presentation.
• You have good verbal and written communication skills

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, if applicable. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 

Employees must be able to wear personal protective equipment (PPE) as required by the area of work or tasks being performed. Required PPE may include, but is not limited to, eye protection, hearing protection, safety shoes, gloves, or additional protective clothing.

If this sounds like you, we want you on our team.  Apply today and let's create something beautiful!

Your Dreams. Our Future.

#NYLaw #LI-Onsite

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.

Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law