Specialist II, QA Document Control

Job 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 Specialist II, QA Document Control in Boca Raton, FL !

Job Title :

Specialist II, QA Document Control

Job Description : Position Summary

The Specialist II, QA Document Contro performs a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements. Writes, revises, processes cGMP documents such as : Standard Operations Procedures (SOPs), Forms, and Batch Records. May conduct investigations related to manufactured products.

Essential Functions (ES) and Responsibilities

• Coordinates projects as assigned by management such as developing new procedures.
• Ensures regulatory compliance as defined in government regulations CFR 210, 211, and 600.
• Writes, reviews, and processes SOPs, investigational reports, and other controlled documents.
• Discusses and researches fundamental technical and regulatory issues.
• Understands, originates, and processes QA Quality System documents such as deviations, CAPAs, change controls, and OOSs.
• Reviews all QA system documents and makes suggestions for continuous improvement and efficiency.
• Trains others in the approval process for QA system documents such as deviations, change controls, CAPAs and protocols.
• Proficient in cGMPs.
• Develop and execute monthly reporting of Quality Systems Key Performance Indicators (KPI), track and trending (QSRB), and training tasks.
• Provide leadership on work scheduling and prioritization.
• Proficiency in computer systems requirements, validations, role, and training assignments.
• Willingness to take on new projects.

Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP’s and procedures with great attention to detailFDA AdherenceExperience Requirements

Education Requirements : High school diploma required.

Experience Requirements : 3-5 years’ experience in pharmaceutical or biotechnology industry or other related industry.

Preferred Experience Compliance Requirements (ES)

As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated / escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.

Job Description Footer :

In addition to competitive compensation, we offer a comprehensive benefits package including :