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Field Quality Manager

Location: New York, New York
Department: Quality Assurance
Hours: 40+

JOB DESCRIPTION:

The Field Quality Manager will be responsible for supporting the company’s short and long-term goals for maintaining compliance with respect to contract manufacturing and associated product quality requirements, applicable regulations, guidance documents including, responsibility for implementing, managing, conducting QA audits of products, and suppliers, including timely inspection and release of products at contract manufactures.

JOB RESPONSIBILITIES:

  • Organize and promote quality and compliance improvement efforts for contract manufacturing inspection and release process
  • Team Player involved in Incoming/Outgoing Component/Finished goods inspections when so identified
  • Will be responsible for creating/providing field quality inspection reports for various inspection level criteria
  • Understand the process of product development and be able to involve early on to understand customer requirements for field quality related functions. In addition, be able to provide insight to quality processes and test that are required to ensure compliance with customer requirements
  • Work with all internal teams including operations, package development, regulatory to provide accurate data as related to field inspections. Work with appropriate teams to not only identify defects but to find the cause and develop a long-term solution
  • Quality oversight for contract manufacturers, and support areas to solve problems and provide expertise on compliance, quality issues as it relates to Maesa products and components
  • Identifies cGMP inadequacies associated with contract manufactured products that can impact product quality compliance including, performance, safety and regulatory compliance in order to prevent costly product non-conformance, recalls, withdrawals and regulatory actions
  • Proactively work with suppliers to improve their internal quality systems to reduce non-conformances
  • Make decisions that can have far reaching results in terms of rejected batches, stock withdrawals, quarantined goods, revised production and marketing schedules and added manufacturing costs
  • While it is expected that discussions of serious problems with management and obtaining of concurrence before taking any action of particular significance will occur, this person must be willing and able to play a vital role in the overall decision-making process and on-site implementation pertaining to the quality problem
  • Conduct product quality audits and line start up inspection at contract manufacturers
  • Conduct quality audits of potential new and/or existing contract manufactures, distribution center laboratories, as applicable. Schedule and perform routine audits with suppliers to routinely identify potential weaknesses in their processes and partner to improve their internal control processes
  • Provide QA review and approval of contract manufacturing deviations, product complaints, input to CAPAs, SOPs, change controls, training documentation, field alerts and protocols/reports. Ensures completeness, accuracy and compliance of all documentation 
  • Leads, manages or participates in quality projects and teams to implement quality systems improvements to meet quality goals and requirements, including drafting and implementing standard operating procedures
  • Responsible for highlighting quality performance data as it relates to contract manufacturing.
    Assures that all contract manufactures adhere to applicable Fill and Assembly stated requirements through the review of appropriate documentation
  • Assures efficient investigation of customer complaints as required and nonconforming product in accordance with cGMP and Maesa procedural requirements
  • Assist in the internal QA lab activities as required (visual inspection, stability/compatibility testing, color and olfactory evaluations, packaging hard component issues troubleshooting)

REQUIRED SKILLS:

  • Bachelor's degree in the sciences (or equivalent work experience)
  • Minimum of 5 years cosmetic/pharmaceutical manufacturing experience and at least 3 of those years in a progressive challenging QA/QC department in the cosmetic, OTC drugs, pharmaceutical or related industry
  • Ability to work 90% of the time at local contract manufacturing base
  • Must have direct experience with Incoming/Outgoing finished goods inspections and MIL standard inspection protocols
  • Have related experience in knowing different level inspection techniques
  • Must have an in-depth knowledge of cGMP and Quality Concepts as well as FDA trends and guidelines
  • Must possess exceptional communication, interpersonal skills, negotiation and problem resolution skills
  • Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company’s needs
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