Specialist, Quality Assurance

Shiseido • East Windsor, NJ

60d

About The Position

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 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

• You are a motivated, self-starter with a bachelor's degree and minimum of 3 years' experience in similar role (relevant work history and/or experience may be considered)
• You are familiar with ISO 22716 standard.
• You are familiar with root cause analysis tools and are strong in math and statistical analysis.
• You can read and interpret specifications and drawings.
• You have hands-on experience with basic measuring equipment.
• You are proficient in MS-Office suite (Excel, Word, PowerPoint, Visio).
• You are a strong communicator with ability to influence across all levels of the organization.
• You are agile and adaptable to changes in a fast-paced work environment with the ability to manage competing demands and frequent changes, delays, and unexpected events.
• You can work independently, requiring minimum supervisory direction.
• You can lift, stand or walk constantly all shift as needed.

Nice To Haves

• Auditor Certification preferred
• You are an ASQ - Certified Quality Improvement Associate (CQIA) (highly desired)

Responsibilities

• You will 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.
• You will lead and support audits and ensure proper resolution of all findings.
• You will drive the Quality Vendor Compliance Manual training.
• You will 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.
• You will compile, maintain and report on customer specific data trending.
• You will ensure assigned CMs meet target PPM goals while meeting all quality standards.
• You will do all other duties assigned
• You may be required to travel (0-10%)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level