Director Quality Control

4 weeks ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

Job DetailsLevelSeniorJob LocationADMA Biologics - Boca Raton, FLRemote TypeN/APosition TypeFull TimeEducation LevelGraduate DegreeSalary RangeUndisclosedTravel PercentageUndisclosedJob ShiftUndisclosedJob CategoryQA - Quality ControlDescriptionADMA Biologics is a bio pharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the bio pharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. ADMA Biologics currently has an opening for a Director of Quality Control in Boca Raton, FL.The Director of Quality Control is responsible for technical, quality, and managerial oversight specific to the Quality Control Department to support the Company's existing products and production. Work performed must adhere to all Company SOP's, policies, and requirements under GMP, and must always operate within the guidelines of maintaining operational excellence. Responsible for directing the Quality Control Department objectives aimed at continuous improvement and strict adherence to cGMP guidelines, maintaining knowledge of new guidance as applicable. The incumbent will also evaluate and advise on additional improvements to the processes within the Quality Control Laboratories from operational perspective, quality, and technical perspectives. The position requires the incumbent to maintain effective communication with all levels of personnel at ADMA and work collaboratively with other departments while keeping Senior Management informed of department activities.QualificationsServe as an ADMA expert for Quality Control Chemistry, Bioanalytical, Raw Material, Microbiology, Stability, and Lab Support departments to support testing and ensure the highest level of product quality. Act as project director and/or sponsor, as required. Will provide day to day hands on management oversight of Quality Control Department.Actively partner with Analytical Development, QA, Regulatory, Compliance, EHS, Project Management, Senior Management and other teams as needed or as directed.Oversight of all processes and procedures related to the testing of ADMA products, ensuring that they meet the cGMP and BLA requirements and, where necessary, provide technical expertise and oversight of the change control process and requisite protocol development and execution. Oversight of all cGMP guidelines for Quality Control Testing.Responsible for oversight relating to the maintenance and evaluation of all control charts within the Quality Control Laboratory. This role is responsible for trending assay controls, invalid rates, training and development of analysts, and identification of reagents suspectible to supply chain disturbances. Write/Review/Sign qualification protocols and reports, controlled documents for Quality Control. Maintain broad knowledge and expertise in state-of the-art methods and procedures by securing a network of contacts within the industry, reviewing new quidanaces, attending conferences and seminars, and general continuing education. Design and implement departmental protocols as required. Assist process development and process validation and analytical development studies by supporting QC testing as required. Support tech transfer of new methods from analytical development and contract laboratories to the Quality Control Laboratory. Maintain knowledge and understanding of applicable compendial methods and updates.Direct optimization of Qualitry Control operational practices from inventory management, to testing schedules, and maintaining invalid and aborted assay rates at an acceptably low level. Provide direction and review for all Quality documents arising from the Quality Control Department, including stability reports, protocols, deviations, laboratory investigations, and others as needed. Ensure that all documents that are sent for review from the department(s) to the QA team are of the highest quality in content and style and can be shared with and presented to the FDA as required. Plan and prepare the budget for the Quality Control Department.Education Requirements: A master's degree in microbiology, Biochemistry, Chemistry, or Analytical Chemistry/Bioanalytical Chemistry is required. A PhD master's degree in microbiology, Biochemistry, Chemistry, or Analytical Chemistry/Bioanalytical Chemistry is preferred. Experience Requirements: A minimum of 10 years in similar cGMP environments with broad knowledge of Quality Control procedures, bioanalytical, chemistry, microbiology assays for sterility, endotoxin, TOC, and stability programs required for biologic therapies. Proven leadership experience required. In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental Insurance Pet Insurance Company paid STD and LTDCompany Paid Holidays 3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailCompany paid shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. ADMA Biologics is an Equal Opportunity Employer.

  • Director Quality Control

    1 month ago

    Boca Raton, United States ADMA Biologics Full time

    Job DetailsLevel SeniorJob Location ADMA Biologics - Boca Raton, FLRemote Type N/APosition Type Full TimeEducation Level Graduate DegreeSalary Range UndisclosedTravel Percentage UndisclosedJob Shift UndisclosedJob Category QA - Quality ControlDescription ADMA Biologics is a bio pharmaceutical company relentlessly committed to creating superior products for...

  • Director Quality Control

    1 week ago

    Boca Raton, United States ADMA Biologics Full time

    Job DetailsLevel SeniorJob Location UndisclosedRemote Type N/APosition Type Full TimeEducation Level Graduate DegreeSalary Range UndisclosedTravel Percentage UndisclosedJob Shift UndisclosedJob Category QA - Quality ControlDescription ADMA Biologics is a bio pharmaceutical company relentlessly committed to creating superior products for immunodeficient...

  • Director, Quality Operations

    2 weeks ago

    Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

    Job DetailsLevelManagementJob LocationADMA Biologics - Boca Raton, FLPosition TypeFull TimeEducation Level4 Year DegreeJob ShiftDayJob CategoryQuality AssuranceDescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved...

  • Senior Director, Quality Systems and Audits

    1 day ago

    Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

    Job DetailsJob Location ADMA Biologics - Boca Raton, FL DescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If...

  • Manager Quality Control Microbiology

    4 weeks ago

    Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

    Job DetailsLevelManagementJob LocationADMA Biologics - Boca Raton, FLPosition TypeFull TimeEducation Level4 Year DegreeJob CategoryQA - Quality ControlDescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved...

  • Manager Quality Control Microbiology

    15 hours ago

    Boca Raton, United States ADMA Biologics Full time

    Job DetailsLevel ManagementJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category QA - Quality ControlDescription ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved...

  • Quality Control Engineer- Civil Design/Land Development

    1 month ago

    Boca Raton, United States Bohler Full time

    Overview At Bohler, we empower the ambitious to become the accomplished. We are looking for a dependable, responsible, and detail-oriented Quality Control Engineer to join our Southern division. Our team is is looking for a Subject Matter Expert who embodies this purpose. What you'll do: Provide high-level strategy for unique design projects...

  • Regional Director

    2 weeks ago

    Boca Raton, United States BlueTeam Full time

    Job DescriptionJob DescriptionRegional Director - Private Sector - BlueTeamWe are…U.S. based service provider specializing in commercial restoration, construction, and roofing — both domestic and international — and our clients are the world’s premier commercial portfolio owners and operators.We are a turnkey provider for portfolio managers, owners,...

  • Outsourced Controller/CFO

    4 weeks ago

    Boca Raton, United States Blank Space Consultants Full time

    Job DescriptionJob DescriptionWe are currently seeking a passionate, personable and hands-on accountant to guide our clients and provide consultative accounting, advisory and analytics services while simultaneously helping clients accomplish their monthly goals. The ideal candidate should be comfortable working at different client locations and interacting...

  • QA Specialist I

    15 hours ago

    Boca Raton, United States ADMA Biologics Full time

    Job DetailsLevel EntryJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level High SchoolTravel Percentage NoneJob Shift DayJob Category QA - Quality ControlDescription ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our...

  • Senior Director of Tax

    4 weeks ago

    Boca Raton, United States Aligned Solutions Full time

    Job DescriptionJob DescriptionA growing, multi-state company in the manufacturing and retail space is looking for a Senior Director of Tax to join its organization. Job Description:1. Overseeing areas such as income tax, motor fuel tax, sales tax, property tax, and unclaimed property reporting. Assessing resource requirements and determining the optimal...

  • Senior Director of Tax Hybrid

    3 weeks ago

    Boca Raton, United States Aligned Solutions Inc Full time

    A growing, multi-state company in the manufacturing and retail space is looking for a Senior Director of Tax to join its organization. Job Description: 1\. Overseeing areas such as income tax, motor fuel tax, sales tax, property tax, and unclaimed property reporting. Assessing resource requirements and determining the optimal balance between external and...

  • Quality Assurance

    7 days ago

    Boca Raton, United States FlexShopper Full time

    Job DetailsJob Location Boca Raton - BOCA RATON, FL Position Type Full Time Education Level 2 Year Degree Salary Range $18.00 - $21.00 Travel Percentage None Job Shift Any Job Category Customer Service Description Responsibilities To support FlexShopper standards and establish goals for the development of staff as they pertain to call quality and control,...

  • Director, Accounting and Finance Advisory Services

    4 weeks ago

    Boca Raton, United States Atlantix Partners Full time

    Job DescriptionJob DescriptionThis is a remote role, but prospects in EST or CST time zone location are preferred.Want to make an impact? Come join us!Job DescriptionThe Director of Advisory Services will support the Senior Managing Director leading the firm's fastest-growing segment, the Advisory Services line. This position will include leading large...

  • Director of Tax

    1 week ago

    Boca Raton, United States Vensure Employer Services Full time

    Essential Duties and ResponsibilitiesIncluding income tax, motor fuel tax, sales tax, property tax, and unclaimed property reporting, determining resource needs and evaluating appropriate split between external vs. internal preparation and consultation. Identifies accretive planning opportunities on an ongoing basis. Proactively communicates relevant...

  • Practice Director

    2 weeks ago

    Boca Raton, United States American Radiologist Network, Inc Full time

    Job Description Job Description We are seeking a Practice Director to join our team! You will be responsible for the quality and quick turnaround of our diagnostics report. Responsibilities: Ensure quick turnaround of quality reports to our referring physicians Review report for any error and or completeness Monitor Physician workflow and...

  • Practice Director

    4 weeks ago

    Boca Raton, United States American Radiologist Network Inc Full time

    Job DescriptionJob DescriptionWe are seeking a Practice Director to join our team! You will be responsible for the quality and quick turnaround of our diagnostics report.Responsibilities:Ensure quick turnaround of quality reports to our referring physiciansReview report for any error and or completenessMonitor Physician workflow and schedulesCommunicate with...

  • Senior Process Controls Engineer

    2 weeks ago

    Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

    Job DetailsLevelExperiencedJob LocationADMA Biologics - Boca Raton, FLRemote TypeN/APosition TypeFull TimeEducation Level4 Year DegreeSalary RangeUndisclosedTravel PercentageUndisclosedJob ShiftUndisclosedJob CategoryEngineeringDescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient...

  • Director of Product Development and Marketing

    1 week ago

    Boca Raton, United States Cosmetic Solutions Full time

    Job DescriptionJob DescriptionWho we are:Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market. Providing world class...

  • Senior Process Controls Engineer

    15 hours ago

    Boca Raton, United States ADMA Biologics Full time

    Job DetailsLevel ExperiencedJob Location ADMA Biologics - Boca Raton, FLRemote Type N/APosition Type Full TimeEducation Level 4 Year DegreeSalary Range UndisclosedTravel Percentage UndisclosedJob Shift UndisclosedJob Category EngineeringDescription ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for...