Quality Assurance Specialist
4 weeks ago
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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