Associate Specialist, Quality Assurance

Shiseido Company, Limited; Windsor (CO); On-site; USD 65,992 - 90,739; Full time

Job summary

Shiseido Company, Limited is hiring an Associate Specialist in Quality Assurance for its East Windsor facility. This role entails preparing FDA reports, releasing finished goods, and ensuring compliance with GMP requirements.

The ideal candidate will have a Bachelor's degree in Engineering or Science and at least two years of relevant quality assurance experience. Strong skills in SAP and proficiency in Excel and PowerPoint are essential for success in this position.

Qualifications

• Bachelor’s degree (B. A.) from a four-year college or university.
• Two years of knowledge of pharmaceutical GMP documentation.
• Experience with quality assurance in a regulated industry.
• Understanding of 21CFR (Part210-211), ICH guidelines.

Responsibilities

• Prepare and complete the CARES act report for FDA.
• Review and approve BOM, set up system specifications for Finished Goods.
• Release Finished Goods and prepare master production records for OTC products.
• Review raw materials, packaging materials and ensure GMP compliance.
• Conduct Annual Product Review of OTC products.

Skills

Knowledge of pharmaceutical GMP documentation

Quality assurance experience in a regulated industry

Expert in Excel and PowerPoint

Good verbal and written communication skills

Education

Bachelor’s degree in Engineering or Science

Tools

SAP systems

Job description

Associate Specialist, Quality Assurance

Date: May 14, 2026

Location: East Windsor

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

What You Will Do

• You will prepare and complete the CARESS ACT list for FDA.
• You will complete BOM review and approval, set up the system specifications for Finished Goods, FG, and Bulk working closely with different departments.
• You will be responsible for Releasing Finished Goods (OTC, Non-OTC, etc.).
• You will prepare master production records for all OTC products.
• You will review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
• You will 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.
• You will aid in investigations as required.
• You will file and maintain batch production and control records for OTC product.
• You will conduct/review Annual Product Review of OTC products. Record the observations that needs follow up with AIC team.
• 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 in any projects/tasks assigned by the Manager.

Who You Are

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

Physical Requirements

Standing: Under 1/3

Walking: Under 1/3; Over 2/3

Use hands to finger, handle or feel: Not Applicable

Climb or balance: Under 1/3

Reach with hands and arms: Under 1/3

Stoop, Kneel, Crouch, or Crawl: Not Applicable

Up to 10 pounds: Under 1/3

Up to 25 pounds: Under 1/3

Up to 50 pounds: Not Applicable

Up to 100 pounds: Not Applicable

Salary (Min-Max): 65,992-90,739

Job Segment: QA, Facilities, Quality, Operations, Research