Job Details
Level
Experienced
Job Location
ADMA Biologics FL - Boca Raton, FL
Remote Type
N/A
Position Type
Full Time
Education Level
Undisclosed
Salary Range
Undisclosed
Travel Percentage
Undisclosed
Job Shift
Day
Job Category
Undisclosed
Description
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 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 biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Quality Assurance Specialist in Boca Raton, FL!
The Senior Quality Assurance Specialist performs a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements. Primarily responsible for the efficacy and compliance of the change control management system, validation and qualification systems, Corrective Action and Preventive Action (CAPA) reports and risk management policies and procedures.
Qualifications
- Conducts Change Review Board (CRB) to ensure that changes are initiated, evaluated, properly classified, authorized and implemented in accordance with Regulatory and Corporate requirements.
- Coordinate and perform any additional activities or projects including the development of new procedures as assigned by QA management.
- Perform QA review and approval of equipment, process, automation, PD, IT, QC, AD, cleaning and stability validation protocols and reports.
- Proficient in cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures.
- Resolve fundamental technical and regulatory issues, as well as resolve and negotiate quality related issues, as needed.
- Utilize Quality Risk Management to identify, assess, control and review any potential impact to process, product or equipment. Suggests and initiates quality improvement plans.
- Work closely with the Validation team and provide support to ensure documentation is accurate and complete.
- Write and perform QA review and approval of additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
- Write and perform QA review and approval of Change Control and Corrective Action Preventive Action (CAPA) Quality Systems. Independently evaluate required supporting documentation to support change and corrective/preventive actions.
- Assist with internal, customer and regulatory audits.
- Assist with new employee and on-going cGMP and quality related training as required.
Education Requirement:
Bachelors Degree required in a field related to the title of the position.
Experience Requirements:
Five to eight years experience in the pharmaceutical or biotechnology industry. Minimum of four years experience in FDA/CBER regulated industry.
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
- Free 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.
What We Do
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates.
