Senior Specialist, Quality Assurance

Date:  Nov 27, 2022
Location:  East Windsor
Company:  Shiseido
Country/Region:  US
Department: 
Custom Field 4:  Employee (Permanent)
Company:  Shiseido

Job Summary:                                                                                                                                                                             

This position is part of Quality External Operations Group. Under the supervision of the Quality Assurance Manager, the Senior 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 and timely closure of all findings with the Contract Manufacturers.
  • Capable of trouble-shooting bulk manufacturing, filling, and packaging related challenges.
  • Participates in the Quality Vendor Compliance Manual revisions and 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 trending of customer complaints and NCP reports, and compile reports 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.
  • Support training initiatives (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, ADC Assembly, 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.

 

Competencies:

Our Principles serve as the working principles that every Shiseido employee must follow. These eight working principles – known as “TRUST 8” – are based on the idea that mutual trust is the key to succeeding in Our Mission.

  1. THINK BIG – Adapt a big-picture perspective. Deliver new values through creativity.
  2. TAKE RISKS – Embrace risk. Practice “Trial & Error & Trial”.
  3. HANDS ON – Consider front-line realities when making decisions. Take the lead from end-to-end.
  4. COLLABORATE – Break free from the silo mentality. Leverage the diverse capabilities of colleagues.
  5. BE OPEN – Be transparent. Create an environment that encourages everyone to speak up – even if it is bad news.
  6. ACT WITH INTEGRITY – Be sincere and humble at all times.
  7. BE ACCOUNTABLE – Commit to the goal. Take accountability for the execution.
  8. APPLAUD SUCCESS – Create a culture that celebrates success.

Must be able to provide documentation of being legally authorized to work in the United States on a full-time basis and not in need of now, or in the future, sponsorship for employment visa status.

Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law.

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