Quality Assurance Manager

3 days ago

Vista, United States Antharis Therapeutics, Inc. Full time

We are excited to offer a unique and rewarding career opportunity for a motivated and experienced Quality Assurance Manager to join Antharis Therapeutics, a cutting-edge pre-clinical company in San Diego. Antharis is dedicated to discovering and developing novel immunotherapeutics, including monoclonal antibodies and antibody-drug conjugates, aimed at treating a wide range of disease states. Our innovative approaches, including hybridoma technology, are designed to accelerate the development of lead candidates for rapid clinical advancement.

We seek a Quality Assurance Manager with proven expertise in antibody discovery, specifically utilizing hybridoma technology. The successful candidate will be responsible for designing and executing immunization and screening strategies to generate diverse panels of antibodies targeting key proteins in oncology and immuno-oncology. In-depth knowledge of the latest advancements in antibody generation technologies is essential, along with the ability to apply these practices at the bench.

This role offers an excellent opportunity to contribute to groundbreaking therapeutic developments while ensuring the highest quality and compliance standards.

Essential Job Functions:

·       Lead the development, implementation, and continuous improvement of quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards.

·       Initiate, manage, and investigate nonconformances and corrective and preventive actions (CAPAs), coordinating necessary activities across departments and external parties.

·       Monitor and manage the effectiveness of quality systems, including deviations, investigations, and CAPAs, utilizing data trending to identify areas for improvement.

·       Ensure final products meet established specifications and end-user expectations by reviewing quality control (QC) data and adjusting product specifications.

·       Act as the subject matter expert (SME) for Quality and Compliance in product development, process characterization, validation, and GMP (Good Manufacturing Practice) activities.

·       Oversee and participate in internal assessments, audits, and regulatory inspections to maintain compliance with applicable regulations and standards.

·       Drive continuous improvement initiatives by implementing best practices, new systems, and process changes to enhance the Quality Assurance function.

·       Develop and revise Standard Operating Procedures (SOPs) and other CGMP documentation to support risk assessments, process validation, and product comparability studies.

·       Manage the GMP Quality System for product development, from clinical phases to commercial manufacturing, ensuring adherence to quality standards.

·       Provide oversight and QA input on risk management activities, regulatory submissions, and GMP facility, equipment, and method qualifications.

·       Ensure effective IT quality processes are in place and provide guidance on compliance with regulatory requirements.

·       Monitor regulatory requirements and industry trends, conduct gap analyses, and implement necessary changes to maintain the Quality System’s compliance.

·       Manage GMP training programs, ensuring they cover all relevant regulatory requirements and are implemented effectively.

·       Track and analyze key performance indicators (KPIs) related to quality systems, escalating issues and risks to senior management as needed.

·       Manage and oversee GMP activities performed by third-party vendors, ensuring compliance with internal and external standards.

·       Work collaboratively with cross-functional teams to ensure timely, high-quality completion of projects aligned with scientific and regulatory standards.

·       Hire, train, coach, and develop Quality Assurance specialists, providing leadership and oversight of their activities.

·       Perform additional duties as required.

Qualifications:

  • Minimum of 5+ years of experience in a Quality Assurance role, with at least 7+ years of relevant experience in the biotech, pharmaceutical, or IVD (in vitro diagnostics) industries leading projects, systems, and personnel.
  • Advanced knowledge of manufacturing processes and procedures in the biotech or sequencing industry, including acceptance activities, production and process controls, traceability, and quality auditing.
  • Proven ability in writing procedures, protocols, and reports and driving investigations to root cause.
  • Bachelor's degree in life sciences (e.g., Chemistry, Biology, Microbiology, Biochemistry), pharmacy, or a related engineering field.
  • Relevant certifications (e.g., ASQ, SQA, ISO) are preferred.
  • Working knowledge of CGMP requirements for biologics manufacturing, aseptic manufacturing, and basic understanding of cell biology and cell culture.
  • Strong problem-solving and analytical skills to proactively identify and address issues with a solution-oriented approach.
  • Ability to interpret and apply CGMP requirements effectively, ensuring compliance with regulatory standards.
  • Superior organizational skills, with the ability to manage and prioritize multiple projects simultaneously, ensuring timely completion of assignments and meeting deadlines.
  • Proven ability to lead teams and work collaboratively within matrix organizations to drive performance and foster partnerships.
  • Strong communication skills (both verbal and written) to maintain alignment between internal and external stakeholders.
  • Track record of managing performance metrics and improving processes for enhanced quality outcomes.
  • Strong drive for quality and continuous process improvement.
  • Self-starter with high energy, initiative, and independence, capable of instilling a sense of urgency and pace within the team.
  • Demonstrated ability to move fast and make decisions decisively, with a passion for working in a growing company.
  • Collaborative and creative mindset, willing to take prudent risks to drive transformative treatments for patients.
  • Focus on achieving challenging timelines through superior planning, risk assessment, and inspiring teams to work efficiently.
  • Committed to building partnerships and fostering a collaborative work environment, prioritizing company and team success over personal goals.

Benefits:

·       Compensation based on relevant experience, skill set, and market factors.

·       401(k) plan with employer match.

·       Comprehensive wellness program, including medical, dental, and vision coverage.

  • ·       Unlimited time off policy.

  • Quality Assurance Manager

    3 months ago

    Vista, United States Western CNC Full time

    Job DescriptionJob DescriptionExperienced CNC Quality Control:We are a fast pace, large CNC machine shop looking for a Quality Assurance Manager25+ Fanuc controlled vertical mills16+ controlled horizontal mills10+ CNC lathes with Fanuc controls10+ Brother milling machines6+ Hass milling machines2 Swiss machinesResponsibilities:First article inspections of...

  • Quality Assurance Engineer 3

    3 months ago

    Vista, United States Enovis Full time

    Job Description: At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of...

  • Senior Vice President of Quality Assurance

    2 weeks ago

    Vista, California, United States CLevelCrossing Full time

    Company OverviewThe Swiss-based Group is a publicly traded, innovation-focused organization that excels in the development and production of peptides and oligonucleotides. As a comprehensive service provider, the company offers products for both clinical development and commercial applications, alongside an extensive catalog and specialized custom...

  • CNC Quality Assurance Supervisor

    1 week ago

    Chula Vista, California, United States Western CNC Full time

    Position Overview: CNC Quality Assurance SupervisorWe are a dynamic and large-scale CNC machining facility looking for a committed Quality Assurance Supervisor to oversee our quality control processes.Key Responsibilities:Perform first article inspections, in-process evaluations, and final assessments of both machined components and sourced...

  • Quality Assurance Inspector

    2 weeks ago

    Vista, California, United States Verify Full time

    Overview:Industry: AerospacePosition: Quality Assurance InspectorLocation: Not specifiedDuration: Not specifiedFrequency: Part-timeJob Description:The appointed individual will conduct advanced mechanical evaluations utilizing precision calibrated instruments.The inspector will guarantee that only compliant components are introduced to the production...

  • Quality Assurance Specialist

    2 weeks ago

    Chula Vista, California, United States BIO FILM INC Full time

    About BioFilm IncCompany OverviewBioFilm Inc is a prominent manufacturer and distributor of premium medical devices and personal care products, dedicated to enhancing the well-being of our customers. Our flagship product, ASTROGLIDE, stands as a leading brand in the personal lubricant market. Our corporate headquarters is located in Vista, CA, where we house...

  • Quality Assurance Specialist

    2 weeks ago

    Chula Vista, California, United States BIO FILM INC Full time

    About BioFilm IncCompany OverviewBioFilm is a manufacturer and distributor of premium medical device and personal care products dedicated to enhancing consumer well-being. Our flagship offering, ASTROGLIDE, stands as a leading brand in the personal lubricant market. Based in Vista, CA, our operations encompass sales, marketing, consumer engagement, research...

  • Systems Quality Assurance Engineer

    2 weeks ago

    Vista, United States Leidos Full time

    Company Overview:Leidos is a leader in providing innovative solutions in the field of security and technology. Our Security Enterprise Solutions (SES) division is dedicated to developing advanced systems that enhance safety and efficiency in global travel and trade.Position Summary:We are currently seeking a Systems Quality Assurance Engineer to be part of...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bella Vista, Arkansas, United States Walmart Full time

    Position OverviewAbout the Team:The People Technology division is at the forefront of enhancing associate experiences. We are on a mission to leverage design and programming expertise to tackle significant challenges that affect countless individuals.As a Senior Quality Assurance Engineer, you will play a pivotal role in our People Technology and Services...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Chula Vista, California, United States General Dynamics Information Technology Full time

    Position Overview:As a Senior Quality Assurance Specialist, you will engage in a comprehensive range of quality assessment activities on products, materials, and components throughout various phases of the manufacturing process to ensure adherence to quality and reliability benchmarks.Key Responsibilities:Conducts diverse quality control evaluations and...

  • Director of Clinical Operations and Quality Assurance

    5 days ago

    Chula Vista, California, United States GLIA HEALTH MANAGEMENT LLC Full time

    Job DescriptionThe Director of Clinical Operations and Quality Assurance is a key leadership position at Glia Health Management LLC, responsible for overseeing the day-to-day activities and development of our clinics. This role ensures that our organization is managed and performing efficiently and effectively, with a focus on delivering high-quality patient...

  • Quality Assurance Technician

    4 weeks ago

    Vista, United States Reser's Fine Foods Full time

    General SummaryMonitors key process control points during production operations. Documents and reports any food safety or quality issues so that corrective actions can be taken. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future....

  • Quality Assurance Analyst

    2 weeks ago

    Chula Vista, United States Child Development Associates Full time

    Employment Type: Full-time | Exemption Status: Non-Exempt Hourly Rate: $28.74 (equivalent to $59,779.20 annually) Location: Eastlake About CDA: Child Development Associates, Inc. (CDA) provides families with the resources necessary to achieve self-sufficiency and thrive. Founded by Charlene Tressler in 1974, CDA has evolved from a one-classroom child...

  • Nondestructive Testing Quality Assurance Specialist

    2 weeks ago

    Chula Vista, California, United States General Dynamics Information Technology Full time

    Type of Requisition:RegularClearance Level Must Currently Possess:NoneClearance Level Must Be Able to Obtain:SecretSuitability:Public Trust/Other Required:NoneJob Family:SCAJob Qualifications:Skills:Magnetic Particle Inspection (MPI), Nondestructive Testing (NDT), Quality Assurance (QA)Certifications:Experience:0 + years of related experienceUS Citizenship...

  • Claims Quality Assurance Specialist

    2 weeks ago

    Chula Vista, California, United States Community Health Group Full time

    Job OverviewPOSITION SUMMARYThe Claims Quality Assurance Specialist is responsible for enhancing and sustaining the precision and quality of claims processed by Community Health Group. This role involves conducting thorough pre-disbursement evaluations for fee-for-service claims. The specialist will gather, monitor, and analyze audit outcomes, while also...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bella Vista, Arkansas, United States Walmart Full time

    Position OverviewAbout the Team:People Technology is at the forefront of enhancing associate experiences at Walmart. We are looking for a Senior Quality Assurance Engineer to play a pivotal role in delivering user-focused mobile and web applications.Key Responsibilities:Collaborate with cross-functional teams to design and implement testing strategies for...

  • Quality Assurance Rep I NDT

    1 month ago

    Chula Vista, United States General Dynamics Information Technology Full time

    Type of Requisition:RegularClearance Level Must Currently Possess:NoneClearance Level Must Be Able to Obtain:SecretSuitability:Public Trust/Other Required:NoneJob Family:SCAJob Qualifications:Skills:Magnetic Particle Inspection (MPI), Nondestructive Testing (NDT), Quality Assurance (QA)Certifications:Experience:0 + years of related experienceUS Citizenship...

  • Quality Assurance Specialist

    6 days ago

    Chula Vista, California, United States Chili's Grill & Bar Full time

    About the RoleWe 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.Key ResponsibilitiesFood Preparation and Quality Control: Ensure that food is prepared to company...

  • Quality Administrator

    2 weeks ago

    Vista, United States Protec Arisawa America, Inc. Full time $25 - $30

    Job DescriptionJob DescriptionCompany Description: Protec Arisawa is the global leader in the design and manufacturing of FRP (Fiber Reinforced Plastic) Pressure Vessels for membrane filtration systems. With over 40 years of experience in filament winding, Protec Arisawa is known for high-quality pressure vessels with leading technology. We have three...

  • Quality Assurance Inspector, Shipyard Operations

    1 week ago

    Chula Vista, California, United States Integrated Marine Services, Inc. (IMS) Full time

    Job OverviewWe are looking for a Quality Assurance Inspector to oversee quality control measures within our operations. The successful candidate will execute quality assessments and inspections in alignment with NAVSEA Standard Items and various technical documentation. You will create Test Inspection Plans (TIP) and verify Test Inspection Records (TIR)...