Quality Assurance Specialist

1 month ago

Parsippany, United States Melinta Therapeutics Full time
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 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

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.

  • Quality Assurance Specialist

    2 weeks ago

    Parsippany, New Jersey, United States Melinta Therapeutics Full time

    Job Title: Quality Assurance SpecialistAt Melinta Therapeutics, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Support the development and implementation of quality programs for...

  • Quality Assurance Specialist

    1 week ago

    Parsippany, New Jersey, United States Melinta Therapeutics Full time

    Product Quality SpecialistMelinta 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...

  • Quality Assurance Specialist

    7 days ago

    Parsippany, New Jersey, United States Melinta Therapeutics Full time

    Job SummaryMelinta Therapeutics is seeking a Quality Assurance Specialist to support our GMP quality program and implement quality programs for all commercial and clinical manufacturing operations. The successful candidate will manage GMP compliance for all relevant local requirements for products developed and sold by Melinta Therapeutics.Key...

  • Quality Assurance Specialist

    3 days ago

    Parsippany, New Jersey, United States Open Health Full time

    Job SummaryAs a Quality Assurance Specialist at Open Health, you will play a crucial role in ensuring the accuracy and quality of our creative and digital medical communications deliverables.Key Responsibilities:Highly detailed review of print and digital deliverables for quality assurance and accuracy of editorial, medical, and client comment...

  • Data Quality Assurance Specialist

    5 days ago

    Parsippany, New Jersey, United States AIG Full time

    Data Quality Assurance SpecialistAt AIG, we are reimagining the way we help customers to manage risk. Our Investment Analytics team is looking for a Data Quality Assurance Specialist to play a key role in ensuring the accuracy and reliability of our analytics data.The successful candidate will be responsible for providing data quality analysis,...

  • Quality Assurance Specialist

    4 days ago

    Parsippany, New Jersey, United States Berkshire Hathaway GUARD Insurance Companies Full time

    OverviewBerkshire Hathaway GUARD Insurance Companies is seeking a Quality Assurance Specialist to contribute to our team's success.We are looking to fill this position in a dynamic, fast-paced environment where you will work with software developers and business analysts to test and deploy business processes throughout the organization.Berkshire Hathaway...

  • Quality Assurance Specialist II

    4 days ago

    Parsippany, New Jersey, United States Ferring Pharmaceuticals Inc. Full time

    Job Summary:As a Quality Assurance Specialist II at Ferring Pharmaceuticals Inc., you will play a crucial role in ensuring the quality and integrity of our products. This position involves monitoring production activities, identifying deviations, and implementing corrective actions to maintain compliance with regulatory requirements.Key...

  • Data Quality Assurance Specialist

    4 days ago

    Parsippany, New Jersey, United States AIG Full time

    Data Quality Assurance for Investment AnalyticsAIG is seeking a highly skilled Data Quality Assurance Specialist to join our Investment Analytics team. As a key member of the team, you will be responsible for ensuring the accuracy and quality of data used in investment analytics.Key Responsibilities:Provide data quality analysis, consolidation, and...

  • Commercial Quality Assurance Specialist

    3 days ago

    Parsippany, New Jersey, United States EverBank Full time

    Commercial Quality Assurance SpecialistThe Commercial Quality Assurance Specialist plays a pivotal role in ensuring the highest standards of quality in commercial lending operations. This position is responsible for conducting thorough quality control audits across multiple lines of business, collaborating with functional leaders to document and maintain...

  • Creative Quality Assurance Specialist

    3 weeks ago

    Parsippany, New Jersey, United States OPEN Health Full time

    Job Title: Creative Quality Control SpecialistAt OPEN Health, we are seeking a highly skilled Creative Quality Control Specialist to join our team. As a key member of our medical communications team, you will be responsible for ensuring the quality and accuracy of creative and digital medical communications deliverables.Key Responsibilities:Highly detailed...

  • Data Quality Assurance Specialist

    4 days ago

    Parsippany, New Jersey, United States AIG Full time

    About the Role:We are seeking a highly skilled Data Quality Assurance Specialist to join our Investments Analytics team at AIG. As a key member of our team, you will be responsible for ensuring the accuracy and quality of our analytics data.Key Responsibilities:Control security reference data and transaction processing across all functions and asset...

  • Quality Assurance Specialist II

    4 days ago

    Parsippany, New Jersey, United States Ferring Pharmaceuticals Inc. Full time

    Job Description:Ferring Pharmaceuticals Inc. is a leading biopharmaceutical company that pioneers and delivers life-changing therapies. As a Quality Assurance Specialist II, you will play a crucial role in ensuring the quality and safety of our products. Your responsibilities will include monitoring production activities, identifying deviations, and...

  • Auto Total Loss Claims Specialist

    1 month ago

    Parsippany, New Jersey, United States Plymouth Rock Assurance Full time

    Job Title: Auto Total Loss Claims SpecialistWe are seeking a highly skilled Auto Total Loss Claims Specialist to join our team at Plymouth Rock Assurance. As a key member of our Auto Claims Organization, you will be responsible for identifying, negotiating, and settling total losses with insureds and claimants.Key Responsibilities:Negotiate and communicate...

  • Manufacturing Quality Assurance Specialist

    4 weeks ago

    Parsippany, New Jersey, United States Jobot Full time

    Quality Engineer Needed For Growing Aerospace ManufacturerThis is a unique opportunity to join a leading global designer and manufacturer of high-performance lifting and pulling devices for military and civilian aircraft, including rescue hoists, winches, and cargo hooks.About the RoleWe are seeking a Quality Engineer skilled in design and project management...

  • Senior Quality Assurance Specialist

    5 days ago

    Parsippany, New Jersey, United States ATech Placement Full time

    We are seeking a skilled Quality Assurance and Testing Professional to join our team at ATech Placement. As a key member of our infrastructure applications team, you will be responsible for testing and ensuring the quality of our solutions across the entire QA/Test lifecycle of an application, including SIT, UAT, and Functional testing.Mandatory requirements...

  • Aerospace Quality Assurance Specialist

    1 week ago

    Parsippany, New Jersey, United States Actalent Full time

    Job Title: Quality Assurance Engineer for AerospaceJob Description:As a Quality Assurance Engineer for Aerospace, you will develop and implement procedures from various industry and aerospace specifications. You will investigate, assess, and resolve production problems in a team environment and represent Quality for Programs and Customers. Your...

  • Quality Assurance and Testing Lead

    1 month ago

    Parsippany, New Jersey, United States JobRialto Full time

    Job Title: Quality Assurance and Analyst Lead Job Description: JobRialto is seeking a highly skilled Quality Assurance and Analyst Lead to support software application testing and QA efforts. The ideal candidate will have experience with web application testing and QA, as well as a strong understanding of software QA methodologies and tools. Key...

  • Senior Quality Assurance Manager

    4 days ago

    Parsippany, New Jersey, United States Metasys Technologies Full time

    Job Overview:Metasys Technologies is seeking a highly skilled Quality Assurance Lead to oversee the quality of mobile device development and software applications. The ideal candidate will have expertise in software QA methodologies and tools, with a strong focus on ensuring quality in mobile device development.Key Responsibilities:Conduct quality assurance...

  • Quality Assurance Manager

    4 weeks ago

    Parsippany, New Jersey, United States Metasys Technologies Full time

    Lead Quality AnalystParsippany, NJ (onsite) 12+Month ContractOverview:Metasys Technologies is seeking a Lead Quality Analyst to join their team for SPSF/SHARP/GSS Projects. The ideal candidate will have expertise in software QA methodologies and tools, with a focus on ensuring quality in mobile device development and software...

  • Senior Quality Assurance Manager

    4 weeks ago

    Parsippany, New Jersey, United States Metasys Technologies Full time

    Lead Quality AnalystMetasys Technologies is seeking a highly skilled Lead Quality Analyst to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards in mobile device development and software applications.Responsibilities:Conduct quality assurance for mobile device applications using...