Specialist, Quality Assurance

Shiseido • East Windsor, NJ

136d

About The Position

Under the supervision of the Quality Director, the Quality Assurance Specialist ensures compliance with cGMP and company policies, procedures, and specifications. This position ensures that Shiseido cosmetic and OTC products manufactured at CM’s meet specification, Quality protocols and methodology and requirements in accordance with cGMP, company SOP’s and FDA regulations and coordinates resolutions to consumer and/or customer complaints. The Quality Assurance Specialist position supports pilot batching, scale up, line trials, up to first production of new product launches at a contract manufacturer (CM).

Requirements

• Bachelor’s degree.
• Minimum of 3 years’ experience in a similar role.
• Familiarity with ISO 22716 standard.
• Auditor Certification preferred.
• ASQ - Certified Quality Improvement Associate (CQIA) highly desired.
• Familiarity with root cause analysis tools.
• Strong in math and statistical analysis.
• Ability to read and interpret specifications and drawings.
• Hands-on experience with basic measuring equipment.
• Proficient in MS-Office suite (Excel, Word, PowerPoint, Visio).
• Strong communicator with ability to influence across all levels of the organization.
• Agile and adaptable to changes in a fast-paced work environment.
• Ability to manage competing demands and frequent changes, delays, and unexpected events.
• Ability to work independently, requiring minimum supervisory direction.
• Ability to lift, stand or walk constantly all shift as needed.

Responsibilities

• Collaborate cross functionally (R&D, QA, PD, Packaging, NPD, NPC, Planning, Procurement and CM) to ensure a successful product launch and/or investigation resolution leading to root cause and corrective/preventive action.
• Lead and support audits and ensure proper resolution of all findings.
• Drive the Quality Vendor Compliance Manual training.
• Review, coordinate, and author SOP, WI, and forms to ensure accuracy and timely updates and ensure proper closure of each complaint and/or NCP according to these established procedures.
• Compile, maintain and report on customer specific data trending.
• Ensure assigned CMs meet target PPM goals while meeting all quality standards.
• Perform all other duties assigned.
• May be required to travel (0-10%).

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees