Quality Assurance Specialist

16 hours ago

Parsippany, New Jersey, United States Melinta Therapeutics Full time

Product Quality Specialist

Melinta Therapeutics is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities:

  • Support GMP quality program and implement quality programs for all commercial and clinical manufacturing operations to achieve corporate compliance goals.
  • Manage GMP compliance for all relevant local requirements for products developed and sold by Melinta Therapeutics.
  • Promote recognition of quality programs among internal and external customers.
  • Assist with the generation of quality documents/activities such as change control, product complaint, batch review / batch disposition, stability and Annual Product Review.
  • Conduct investigations into GMP-related issues.
  • Support manufacturing and packaging activities including review of executed batch records.
  • Participate in QA activities/oversight of multiple functional areas and Contract manufacturing sites, ensuring consistent application of cGMPs; QSR; ISO 13485, ICH Q8, Q9, and Q10, and other relevant regulations and guidance to assure quality of Melinta products.
  • Work collaboratively with both internal and external clients to resolve quality issues and maintain GMP compliance.
  • Promote a positive work environment by communicating clear direction on corporate goals.
  • Support GMP Quality Management Systems.

Requirements:

  • At least 4 years of experience in commercial GMP operations, of which at least 2 years' experience GMP Quality.
  • Solid understanding of quality management including global cGMP requirements, ISO 13485, ICH Q8, Q9, and Q10, and other relevant regulations and guidance to assure quality of Melinta products.
  • Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of corporate strategic goals.
  • Good written and oral communication skills; proficient in writing (email communications, complaints, investigations, CAPA).
  • Proficient in MS Excel, Word and PowerPoint.
  • Ability to understand a task, assess priority against pending tasks and complete within the given timeframe or provide updates with proposed timelines.
  • Ability to be attentive in meetings, fully participate, share ideas as well as different approaches.
  • Ability to manage multiple product quality and quality system related activities/projects independently.

Education:

  • B.S. or B.A. in Natural Sciences or Science.
  • Certification/training in applicable quality management disciplines.

Position Type:

  • Full Time (In Office/Hybrid Schedule).

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