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Specialist, Quality Assurance

Location: East Windsor, New Jersey Brand: Shiseido Date: 11/23/2021

Division:  SAI

Hiring Manager:  Manager, Quality Assurance

Department:   Supply Chain

Supervisor:   Manager, Quality Assurance

Direct Reports:    none

Job Title:  Specialist, Quality Assurance

Job Summary:

The Specialist, Quality Assurance is responsible for reviewing specifications, procedures, protocols, and records for GMP compliance.  Responsibilities also include GMP audits of the plant, coordinate and track closeouts of deviations, change control requests, consumer complaints, and out-of-specification investigations.

Primary Duties & Responsibilities:

  • Provide assistance writing OOS, Consumer complaint investigation, metrics reports. Present data through meetings and as written documents. Propose appropriate CAPAs to avoid reoccurrences.
  • Administers CAPA system focusing on CAPA approval, closure and database tracking.
  • Conduct Internal Quality Audits. Report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
  • Review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
  • Prepare master production records for all OTC products if assigned.
  • Perform review of batch production and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
  • File and maintain batch production and control records for OTC product.
  • Coordinate and track completion of action items generated due to deviations and change control requests
  • Conduct Annual Product Review of OTC products.
  • Provide GMP Training to other departments as needed
  • Researches and prepares data needed for monthly quality metrics reporting
  • Assist in any project/task assigned by the Manager.

Working Relationships/Key Stakeholders:

  • Production, Manufacturing, Planning, NPC, S&OP, Regional Quality

Qualifications & Competencies: (List required or desired education; competencies; experiences; soft & hard skills)

  • Bachelor's degree, preferably with a Engineering or Science major.
  • Two years experience working with pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
  • Good understanding of 21CFR (Part210-211), ICH guidelines
  • Expert in Excel and PowerPoint presentation.
  • Good presentation skills.
  • Excellent demonstration of verbal and written communication skill

Competencies

Below is a list of Core Competencies designed to help employees at Shiseido Americas succeed as the company continues to evolve and innovate.

  1. Business Insights: Applying knowledge of business and the marketplace to advance the organization’s goals
  2. Customer Focus: Building strong customer relationships and delivering customer centric solutions
  3. Collaborates: Building partnerships and working collaboratively with others to meet shared objectives
  4. Drives Results: Consistently achieving results, even under tough circumstances
  1. Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
  2. Develops Talent: Developing people to meet both their career goals and the organization’s goals
  3. Nimble Learning: Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder
  4. Instills Trust: Gaining the confidence and trust of others through honesty, integrity and authenticity
  5. Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences

Job ID: 6935 Category: Factory

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