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 Specialist I, QA Document Control.
Position Summary
Create, format, revise and proofread controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control. Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.
Essential Functions (ES) and Responsibilities
Create, format, revise, and proofread controlled documents such as Standard Operating Procedures (SOPs), forms, validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control.
Enforce limited access restriction of secured controlled documents in the electronic and physical document locations.
Process documents for approval signatures, official distributions, and obsoletion.
Assist with maintaining inventory of on-site documentation.
Assist with the maintenance of document retention and destruction schedules.
Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies, etc.
Job Responsibilities or Job Requirements
Competencies
Experience Requirements
Education Requirements: High school or equivalent required.
Experience Requirements: 1-2 years of experience with document management systems and
Preferred Experience
Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks’ Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree 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.