PRODUCT QUALITY SPECIALIST
GLOBAL GMP QUALITY ASSURANCE & COMPLIANCE
If you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then Melinta Therapeutics might be the right place for you. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.
Melinta provides innovative therapies for acute and life-threatening illnesses, with commercial and medical capabilities, specializing in infectious diseases and acute care. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.
Position Summary
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.
Duties & Responsibilities
Promote recognition of quality programs among internal and external customersAssist with the generation of quality documents/activities such as change control, product complaint, batch review / batch disposition, stability and Annual Product ReviewConduct investigations into GMP-related issuesSupport 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 compliancePromote a positive work environment by communicating clear direction on corporate goalsSupport 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 productsDemonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of corporate strategic goalsGood written and oral communication skills; proficient in writing (email communications, complaints, investigations, CAPA)Proficient in MS Excel, Word and PowerPointAbility to understand a task, assess priority against pending tasks and complete within the given timeframe or provide updates with proposed timelinesAbility to be attentive in meetings, fully participate, share ideas as well as different approachesAbility to manage multiple product quality and quality system related activities/projects independently
Education
B.S. or B.A. in Natural Sciences or ScienceCertification/training in applicable quality management disciplines
Position Type
Full Time (In Office/Hybrid Schedule)
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.