Director Quality Control

3 weeks ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time
Job Details

Level
Senior

Job Location
ADMA Biologics - Boca Raton, FL

Remote Type
N/A

Position Type
Full Time

Education Level
Graduate Degree

Salary Range
Undisclosed

Travel Percentage
Undisclosed

Job Shift
Undisclosed

Job Category
QA - Quality Control

Description

ADMA 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.

Qualifications

  • Serve 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 vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks' Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Company paid shuttle to the Boca Tri-Rail station

ADMA 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.

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