Specialist, Quality Assurance External Operations

Shiseido Company, Limited; Windsor; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading company in the cosmetics industry is seeking a Quality Assurance Specialist to ensure compliance with quality protocols and FDA regulations. The role involves collaboration across various departments to support product launches and resolve quality issues. Ideal candidates will have a Bachelor's degree and relevant experience in quality assurance.

Benefits

Participation in bonus program

Competitive benefits

Qualifications

• Minimum of 3 years’ experience in a similar role.
• Familiar with ISO 22716 standard.

Responsibilities

• Ensure compliance with cGMP and company policies.
• Collaborate cross-functionally for product launches.
• Lead and support audits.

Skills

Communication

Statistical Analysis

Root Cause Analysis

Education

Bachelor's Degree

Tools

MS-Office

Job description

Specialist, Quality Assurance External Operations

Date : Jan 14, 2025

Location : East Windsor

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).

WHAT YOU WILL DO

• 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.
• Other duties as assigned.
• Travel may be required (0-10%).

WHO YOU ARE

• You are a motivated, self-starter with a bachelor’s degree and minimum of 3 years’ experience in a similar role (relevant work history and / or experience may be considered).
• Familiar with ISO 22716 standard. Auditor Certification preferred.
• ASQ - Certified Quality Improvement Associate (CQIA) is highly desired.
• Familiar with root cause analysis tools and are strong in math and statistical analysis.
• Can read and interpret specifications and drawings.
• Have hands-on experience with basic measuring equipment.
• Proficient in MS-Office suite (Excel, Word, PowerPoint, Visio).
• A strong communicator with ability to influence across all levels of the organization.
• Agile and adaptable in a fast-paced work environment with the ability to manage competing demands and frequent change, delays, and unexpected events.

If this sounds like you, we want you on our team. Apply today and let's create something beautiful!

Your Dreams. Our Future.

The base pay for this position may vary based on geographic location. Actual base pay offered will be based on several factors including job-specific knowledge, education, skills, and depth of experience. In addition to base pay, we may offer additional forms of compensation as components of a total compensation package, including participation in our bonus program which features the ability to overachieve, in addition to a full range of competitive benefits.

J-18808-Ljbffr

Create a job alert for this search

Quality Assurance Specialist • Windsor, Windsor, Canada