Quality Manager

CA - Oxnard

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We areseeking for a Quality Manager

We are seeking for a Quality Manager who can lead and implement quality initiatives including maintaining compliance, troubleshooting issues, and direct personnel.

Position Requirements:

  • Manages Quality continuous improvement initiatives
  • Approves and releases bulk and Finished Goods according to established procedures
  • Makes adjustments to bulk batches that are not within specifications
  • Oversee quality of compounded bulk, assembly of finished goods, order preparation and fulfillment of orders
  • Approves and releases bulk and Finished Goods according to established procedures
  • Work closely with theorganization to provide assistance to all areas with evaluating and resolving OOS (out of specification) issues, standards or specifications
  • Communicates to the appropriate department the status of raw, bulk, Finished Goods and microbiological testing Requests and retrieves technical information (specifications, drawings and standards) from various sources to assist in resolving quality issues and resolve problems as necessary
  • Plans and directs activities concerned with application, and maintenance of quality standards for Manufacturing Processes (Compounding, Finished Goods and or Fulfillment)
  • Ensures standards and methods for inspection, testing, and evaluation are being followed accordingly
  • Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility
  • Directs front line Associates and Quality Operators in matters related to quality
  • Support the development of a continuous improvement strategy for the department
  • Drive product and manufacturing process improvements
  • Ensure that profit plan commitments are met by efficient use of resources and careful execution of testing requirements and associates
  • Ensure completion of staff performance reviews Ensures timely completions of investigation of Out-of-Specification production.
  • Initiate root cause/corrective actions and systems to ensure compliance to quality requirements
  • Perform special projects and assignments in support of the unit or facility as defined by the Quality Director Participates in the routine auditing of facility records for cGMP compliance
  • Able to understand facility processes as it relates to the control and release of quarantined materials such as Finished Goods, Bulk and raw materials
  • Follow safety policies and maintain good housekeeping in work area
  • Makes adjustments to bulk batches that are not within specifications
  • 4+ years of experience in Quality
  • Must be able to effectively communicate, make independent decisions, have proven experience leading change
  • Must be well versed in compliance requirements (i.e. cGMP)
  • Demonstrated ability to deliver strong execution and show sustainable improvement in KPIs and have the ability to work effectively in a team environment
  • Ability to think outside of the box and challenge the status quo
  • Must be able to lead/influence others in the development and implementation of business objectives
  • Must be able to analyze data and have operational understanding to identify, prevent, and solve problems and make decisions in a timely manner
  • Must be able to make immediate decisions with limited information and rapid assimilation of facts
  • Must have the ability to multi-task and take on multiple projects at one time
EDUCATION: Bachelors in related field
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