1 Melinta Therapeutics Job
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Melinta Therapeutics is Hiring a Remote Product Quality Specialist
Position Summary
Duties & Responsibilities
- 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
Qualifications
- 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
Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.
Job Summary
Full Time
Pharmaceutical
$95k-114k (estimate)
09/01/2023
05/08/2024
melinta.com
LINCOLNSHIRE, IL
200 - 500
2000
Private
MARY T SZELA
$50M - $200M
Pharmaceutical
Related Companies
About Melinta Therapeutics
Melinta is a biotechnology company that develops and commercializes novel antibiotics for the treatment of bacterial infections.
The job skills required for Product Quality Specialist include Quality Management, ISO, Packaging, Product Quality, Change Control, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Product Quality Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Product Quality Specialist. Select any job title you are interested in and start to search job requirements.
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