Associate Specialist, Quality Assurance

Shiseido; East Windsor Township (NJ); On-site; USD 65,992 - 90,739; Full time

Job summary

Shiseido is seeking a Quality Assurance Associate Specialist in East Windsor Township, NJ. This role focuses on ensuring FDA compliance, reviewing GMP documentation, and releasing Finished Goods. The ideal candidate has a bachelor's degree in Engineering or Science and at least two years of quality assurance experience in the pharmaceutical sector. You will prepare the CARESS ACT list, conduct quality training, and manage batch records. A salary range of $65,992 to $90,739 per year is offered.

Qualifications

• Two years of quality assurance experience in a regulated industry.
• Understanding of 21CFR (Part210-211) and ICH guidelines.

Responsibilities

• Prepare and complete the CARESS ACT list for FDA.
• Complete BOM review and approval.
• Release Finished Goods (OTC, Non-OTC).
• Review Batch records for GMP compliance.
• Conduct/review Annual Product Review of OTC products.

Skills

Knowledge of pharmaceutical GMP documentation

Quality assurance experience

Expertise in Excel

Good verbal and written communication skills

Education

Bachelor’s degree in Engineering or Science

Tools

SAP systems

Job description

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 need 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

• You have a bachelor’s degree (B. A.) from a four‑year college or university, preferably in Engineering or Science.
• You have two 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

• Standing: Under 1/3
• Walking: Under 1/3
• Sitting: 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 $65,992 - $90,739/ year