Specialist, Quality Assurance

Job Summary:
This position is part of Quality External Operations Group. Under the supervision of the Quality Assurance Senior Manager, 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 and any related company SOP’s and FDA regulations. This role also coordinates resolutions to consumer and/or customer complaints, acting as a liaison with QA/QC, Operations Product Development, R&D, PD, Packaging, and other groups necessary to satisfy customer requests. Requiring very minimal supervision, compiles customer specific complaint data as needed.
The Quality Assurance Specialist position is fully responsible for the support on pilot batching, scale up, line trials, up to first production of new product launches at a contract manufacturer (CM) of both Cosmetic and OTC products.

Primary Duties & Responsibilities:
Liaise between cross functional departments (R&D, QA, PD, Packaging, NPD, NPC) and CM to ensure a successful product launch and/or investigation resolution leading to root cause and corrective/preventive action.
Ability and skill to effectively manage multiple complaints/NCPs simultaneously and drive timely execution.
Ability to lead and support ISO 22716 audits and ensure proper closure of all findings with the Contract Manufacturers.
Capable of trouble-shooting bulk manufacturing, filling, and packaging related issues.
Participates in the Quality Vendor Compliance Manual training (as required).
Review, coordinate, and author SOP, WI, and form(s) in the External Operation Quality Department and support routine review of controlled documents.
Ensure proper documentation, investigation, and closure of each complaint and/or NCP in accordance to established procedures.
Perform weekly, monthly, and customer specific data trending and compile complaint data tables and/or graphs as required
Work with Quality team and CMs to meet target PPM goals and reduce number of repeat complaints and NCPs.
Support department and organizational goals and objectives.
Conduct training to others (both internal and external) to ensure test procedures and work instructions are understood and applied correctly.
All other duties as required and requested.
Some travel required as follow: Local: 0 - 10%
Domestic or concurrent territory: 0 - 10% International: 0 - 5%

Working Relationships/Key Stakeholders:
Horizontal: Quality Specialist, Complaint Specialist, Packaging Engineer, Production Supervisor, Planner, Buyer.
Vertical: Quality Manager, Production Manager, Planning Manager, Buyer Manager
Work side-to-side with contract manufacturers to assure product Quality and compliance to local, state, and federal requirements.
Collaborate with Quality Assurance, Quality Control, Packaging Engineering, NPD, and NPC in the collection of specifications, artwork, standards, etc.

Financial Accountability:
Actively support Finance Department with the resolution of blocked/non- conforming materials at contract manufacturers and/or distribution center.
Adhere to company's T&E policy.

Qualifications & Competencies:
Bachelor’s degree (Relevant work history and/or experience may be considered in lieu of degree) with minimum of 3 years’ experience in similar role
Familiarity with ISO 22716 standard. Auditor Certification preferred
ASQ - Certified Quality Improvement Associate (CQIA) is highly desired
Familiarity with root cause analysis tools
Knowledge in basic math and statistics.
Ability to read and interpret specifications and drawings.
Hands-on experience with basic measuring equipment.
Basic knowledge of MS-Office suite (Excel, Word, PowerPoint, Visio).
Able to lift, stand or walk constantly all shift as needed.
Strong communication and interpersonal skills within all levels of the organization.
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.
Works independently, requiring minimum supervisory direction.
Takes initiative and self-motivated.

Trust 8 Competencies
Below is a list of Trust 8 Competencies designed to help employees at Shiseido Americas succeed as the company continues to evolve and innovate.
Think Big: Adapt a big-picture perspective. Deliver new values through creativity.
Take Risks: Embrace Risk, Practice “Trial and Error and Trial”.
Hands On: Consider Front-line realities when making decisions. Take the lead from end to end.
Collaborate: Leverage the diverse capabilities of colleagues.
Be Open: Create an environment that encourages everyone to speak up.
Act with Integrity: Be sincere and humble at all times.
Be Accountable: Commit to the goal. Take accountability for the execution.
Applaud Success: Create a culture that celebrates success.