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Senior Specialist, Quality Assurance

4 months ago

White River Junction, Vermont, United States Shiseido Full time

Job Summary:

This position is part of the Quality External Operations Group. Under the supervision of the Director, Quality Assurance, the Senior Specialist, Quality Assurance 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 manages 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 and presents customer specific complaint data as needed.

The Senior Specialist, Quality Assurance 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.
  • Manage CM Audits (scheduling, training, audit management, audit tools, etc.)
  • Conduct Training of others to ensure test procedures and work instructions are understood and applied correctly.
  • Coordinates the collection of Quality KPIs and drive continuous quality improvements (systems, processes, people)
  • Effectively manage multiple complaints/NCPs simultaneously and drive timely execution.
  • Lead and support ISO 22716 audits and ensure proper and timely closure of all findings with the Contract Manufacturers.
  • Troubleshooting of 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 with 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:
    • 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 5 years' experience in similar role.
  • Familiarity with ISO 22716 standard. Auditor Certification preferred.
  • ASQ - Certified Quality Improvement Associate (CQIA) is highly desired.
  • Proven experience leading others in achieving department and company's goals, objectives, duties, and assignments.
  • Excellent analytical and problem-solving skills with the ability to identify root-cause, utilize root cause analysis tools to recommend, prioritize, and implement appropriate solutions.
  • 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).
  • Strong communication and interpersonal skills across all levels of the organization.
  • Adaptability to pivot and manage frequent changes, delays, and unexpected events in the work environment.
  • Work independently, requiring minimum supervisory direction.
  • Take initiative and be self-motivated.
  • Able to lift, stand or walk constantly all shifts as needed.
  • Basic math and statistics knowledge

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.

  1. Think Big: Adapt a big-picture perspective. Deliver new values through creativity.
  2. Take Risks: Embrace Risk, Practice "Trial and Error and Trial".
  3. Hands On: Consider Front-line realities when making decisions. Take the lead from end to end.
  4. Collaborate: Leverage the diverse capabilities of colleagues.
  5. Be Open: Create an environment that encourages everyone to speak up.
  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.

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