QA Specialist

At Miyoshi America you will find the opportunity to build your career and develop professionally within a diversified company whose motto is “Treating You Right”. Our culture encourages independent thinking and a team mentality. Consider joining a team of talented and dynamic individuals that are supporting the growth of a Global company.

Responsibilities:

  • Coordinate and implement change control, CAPAs, OOS investigation, approvals, and completions of all quality forms as well as filing.
  • Create and revise GMP related SOPs and forms, maintain SOP Book. Works with all departments to assure that all documents, revisions, forms are maintained, revised, archived, and retrievable and tracked, as necessary, and are in compliance with cGMP regulations.
  • Create, maintain, and update Master Production Control Records, Routings & BOMs; maintain a routing log for product routings.
  • General oversight, management, and troubleshooting for Document Control and Training systems and processes.
  • Perform Internal Audits, completes audit reports, and follows up on action items.
  • Supports Validations and Commercialization processes. Writes validations, as necessary.
  • Reviews and releases Manufacturing Production Control Records
  • Prepares QA Annual Drug Product Review and coordinates with QC’s review.
  • Investigates or supports investigations on customer complaints, deviations, and out-of-specification issues.
  • Create and maintain QA tracking logs, file forms & issue all tracking numbers for quality forms.
  • Interact with Production personnel to resolve discrepancies and deviations.
  • Ensures that product within the plant is consistently manufactured in conformance with MAI Quality System requirements and all applicable regulatory requirements.
  • Provide QA support for assigned interdepartmental projects. These projects can include putting procedures in place for new manufacturing areas, revisions to procedures for updated areas, assisting in implementation of new systems within the quality arena, etc.

Requirements:

  • High School Diploma or GED required, Associates Degree preferred
  • 3 years’ experience in Quality Assurance
  • Strong organizational skills and attention to detail
  • Ability to take initiative and perform duties with minimal instruction or supervision
  • Excellent written and verbal communication skills
  • Ability to work in a team environment, across disciplines, at all levels of the organization, and with external parties
  • Learns fast, grasps the “essence,” and can change course quickly where needed
  • Proficiency in Microsoft Word, Excel, PowerPoint, Access, and an MRP system (e.g. Sage, SAP).
  • Previous experience in GMP manufacturing facility a plus
  • Experience writing validation a plus

This position is located at our Dayville, CT facility