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Shiseido · 7 hours ago

Specialist, Quality Assurance

East Windsor, NJ

Full-time

Onsite

Mid Level

$75K/yr - $113K/yr

3+ years exp

Shiseido Americas is a subsidiary of the world-renowned Shiseido Company Limited, focused on beauty innovations. The Specialist, Quality Assurance, is responsible for reviewing and approving Bills of Materials and ensuring compliance with Good Manufacturing Practices, while also supporting GMP audits and quality assurance functions.

BeautyCosmeticsFashionPersonal Care and Hygiene

Responsibilities

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

Qualification

GMP complianceQuality assurance experiencePharmaceutical documentationSAP systemsExcel expertisePowerPoint presentationVerbal communicationWritten communicationTeam collaborationProblem-solving