About The Position

This position supports quality compliance systems and objectives within the site. The incumbent maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. The role involves reviewing production documents to ensure completeness and accuracy, completing the final disposition of products and packaged production (including raw materials and packaging components), and quarantining production if any atypical observation is made during the production process. The position also generates Certificates of Analysis (CoA) and Certificates of Compliance (C of C) for required production and reports observed deviations. This role will interact with cross-functional groups such as Production, Quality Control, Compliance, Regulatory, EHS, and Production.

Requirements

  • Bachelor’s degree (BBA, BA, BS, or related field)
  • Two (2) to three (3) year years of experience in product disposition or similar role is desired.

Nice To Haves

  • Making sound and effective quality decisions using scientific judgement
  • Exposure to regulatory inspections and interactions with inspectors
  • Evaluating and continuously improving the site quality systems

Responsibilities

  • Review Operations Records (Manufacturing / Packaging/Incoming Materials)
  • Complete final disposition (Release / Rejection) for Product, Incoming Materials
  • Quarantine production
  • Perform Inspections (AQL)
  • Work with reserve and stability samples documentation review
  • Support deviations
  • Generates CoA and CoC
  • Complete the Annual Periodic Product Reviews
  • Write or assists in writing procedures.
  • Evaluates Material Variance Reports
  • Prepares document filing and send to Record Retention Area
  • Prepares Quality Alert Notification and distributes accordingly
  • Participating in Tier Meeting

Benefits

  • Generous 401(k) plan
  • Tuition reimbursement
  • Time off programs
  • 6 months paid parental leave
  • Healthcare programs where the company pays for the majority of your medical coverage for you and your family
  • Discretionary bonus based on the achievement of key business performance
  • Other incentive/recognition programs
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