Quality Assurance Operations Specialist

1 week ago


Albany, New York, United States AmplifyBio Full time
About AmplifyBio

AmplifyBio is a leading contract research organization that provides a comprehensive range of services for the pharmaceutical and biotechnology industries. Our company is committed to growing and empowering an inclusive community within our organization and industry.

Job Summary

We are seeking a highly experienced Quality Assurance Operations Specialist to join our team at AmplifyBio's Manufacturing Enablement Center in New Albany, OH. The ideal candidate will have a strong background in GMP regulation and guidelines, as well as experience in cell & gene therapy manufacturing.

Key Responsibilities
  • Review and approve GMP documentation, including SOPs, batch records, deviations, and investigations.
  • Manage and trend lot/product disposition activities.
  • Provide guidance on Quality topics to foster a quality culture and quality mindset.
  • Investigate and resolve quality issues in a timely and effective manner.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Develop and implement quality metrics and analysis trends.
Requirements
  • Bachelor's degree or higher in a relevant scientific discipline.
  • Minimum of 2/4/8+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities.
  • Extensive cGMP quality system knowledge and experience.
  • Experience using and/or managing eQMS, such as Veeva.
  • Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills.
What We Offer
  • Competitive compensation package.
  • Health, dental, and vision insurance.
  • Flexible PTO policy.
  • Generous paid parental leave.
  • Wellness and self-care programs.
  • 401(k) match.
  • Tuition reimbursement.
  • EAP/work-life support system.
About Our Company

AmplifyBio is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender, sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.



  • Albany, New York, United States Academic Quality Full time

    About the RoleThe Quality Assurance Specialist will provide operational management support within the Academic Quality team, ensuring the consistency of service and effective updates to digital development and e-learning platforms.Key ResponsibilitiesContribute to the coordination and execution of quality assurance audits and reviewsEnsure the accuracy and...


  • Albany, New York, United States Academic Quality Full time

    About the RoleThe Quality and Development Officer plays a critical role in ensuring the consistency of service and effective updates to digital development and e-learning at Academic Quality. This includes ensuring the accuracy and reliability of quality assurance audits and reviews, as well as the coordination and execution of professional development for...


  • Albany, New York, United States Academic Quality Full time

    Academic Quality Job Description **About the Role** The Quality and Development Officer plays a crucial part in ensuring the consistency of service and effective updates to digital development and e-learning. This includes ensuring the accuracy and quality of educational content, as well as the effective use of educational technology and multimedia...


  • Albany, New York, United States American Cybersystems Full time

    Position Overview:American Cybersystems is seeking a dedicated Quality Assurance Specialist to join our dynamic team.Position Type:Permanent.Role Summary:As a Quality Assurance Specialist, you will play a crucial role in ensuring the integrity and performance of our applications. Your expertise will contribute to the overall success of our operations.Key...


  • Albany, New York, United States Chili's Grill & Bar Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Chili's Grill & Bar. As a Quality Assurance Specialist, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food in a timely manner.Key ResponsibilitiesFood Preparation and Quality Control: Ensure that all food is...


  • Albany, New York, United States AmplifyBio Full time

    About AmplifyBioAmplifyBio is a leading contract research organization providing a comprehensive range of services for discovery stage R&D work, preclinical CRO, and manufacturing services for cell, gene, and mRNA-based therapeutics.Job SummaryWe are seeking a highly experienced Quality Assurance Operations Specialist to join our team at AmplifyBio's...


  • Albany, New York, United States AmplifyBio Full time

    About the RoleWe are seeking a highly experienced Senior Quality Assurance Specialist to join our team at AmplifyBio. As a key member of our Quality Assurance Operations team, you will play a critical role in ensuring the quality and compliance of our cell and gene therapy manufacturing operations.Key ResponsibilitiesReview and approve GMP documentation,...


  • Albany, New York, United States Brook & Whittle Full time

    Job SummaryWe are seeking a highly detail-oriented Quality Assurance Specialist to join our team at Brook + Whittle. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality of our products, from inspection to shipping.Key ResponsibilitiesProduct Inspection: Conduct thorough inspections of products to identify any defects...


  • Albany, New York, United States HexaQuEST Global, Inc. Full time

    Job Title: Lead Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Lead Quality Assurance Specialist to join our team at HexaQuEST Global, Inc. The successful candidate will be responsible for leading the quality assurance efforts for complex projects, ensuring that our products meet the highest standards of quality and reliability.Key...


  • Albany, New York, United States Living Resources Full time

    About the RoleLiving Resources is a non-profit human services agency dedicated to supporting individuals with disabilities or life-challenging conditions. We empower them to live with dignity, independence, and happiness.As a Quality Assurance Specialist, you will play a crucial role in ensuring compliance with regulations and maintaining the highest...


  • Albany, New York, United States Zifo Full time

    Job OpportunityZifo is seeking a highly skilled Quality Assurance Specialist to join our team in Albany, NY.About the Role:We are looking for a talented individual to manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area.Key Responsibilities:Author change control documents...


  • Albany, New York, United States Indotronix International Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Indotronix International Corporation. As a Quality Assurance Specialist, you will be responsible for evaluating child/youth cases for compliance with applicable regulations, communicating evaluation requirements, and summarizing compliance findings for the Children's...


  • Albany, New York, United States Kroger Full time

    Company Overview:Tara Foods, a respected division of Kroger Manufacturing, is seeking a Food Safety and Quality Assurance Specialist to join our dedicated team. At Tara Foods, we provide the extensive resources and benefits of a Fortune 500 company while fostering a community atmosphere focused on collaboration, support, and personal growth. Our facility is...


  • Albany, New York, United States Zifo Full time

    Job Title: Quality Assurance AnalystLocation: Albany, New YorkAbout the RoleZifo is seeking a highly skilled Quality Assurance Analyst to join our team in Albany, NY. As a key member of our laboratory IT team, you will be responsible for ensuring the quality and integrity of our systems and processes.ResponsibilitiesManage change controls necessary for...


  • Albany, New York, United States Zifo Full time

    Job Summary:This role will require a 100% on-site presence in Albany, NY. We are seeking a Quality Assurance Analyst to join our team at Zifo, a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations.Key Responsibilities:Manage change controls...


  • Albany, New York, United States Aspire Behavioral Health & DD Services Full time

    Position OverviewOrganizational RelationshipsPosition Title: Clinical Quality Assurance SpecialistEmployee:Work Unit: URUMAdministrative Supervisor: Sonya TaylorClinical Supervisor: Lisa OosterveenQualifications:The ideal candidate will possess a Master's degree in counseling or a related discipline, along with at least an associate level licensure (LAPC,...


  • Albany, New York, United States Blasch Precision Ceramics Full time

    About Blasch Precision CeramicsWe are a leading manufacturer of net shape ceramic and refractory components, serving a wide range of industrial markets worldwide.Our proprietary Blasch Process is a unique, proprietary forming method that produces net shape and near net shape ceramic parts with attractive physical properties.Job Title: Quality Assurance...


  • Albany, New York, United States AmplifyBio Full time

    About AmplifyBioAmplifyBio is a leading contract research organization that provides a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.Job SummaryWe are seeking a Senior Quality Assurance Compliance Specialist to join our growing team. The...


  • Albany, New York, United States AmplifyBio Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Compliance Specialist to join our team at AmplifyBio. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key ResponsibilitiesDevelop and implement quality management systems to ensure compliance with...


  • Albany, New York, United States AmplifyBio Full time

    About AmplifyBioAmplifyBio is a leading contract research organization that provides a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.Job SummaryWe are seeking a Senior Quality Assurance Compliance Specialist to join our growing team. The...