Specialist II, QA Document Control

Specialist II, QA Document Control

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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.

Job Title : Specialist II, QA Document Control

Position Summary : The Specialist II, QA Document Control 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.
• Develops and executes monthly reporting of Quality Systems Key Performance Indicators (KPI), track and trending (QSRB), and training tasks.
• Provides leadership on work scheduling and prioritization.
• Proficiency in computer systems requirements, validations, role, and training assignments.
• Willingness to take on new projects.

Competencies and Experience : Ability to follow the cGMPs and procedures with great attention to detail. FDA adherence.

Education Requirements : High school diploma required.

Experience Requirements : 35 years experience in pharmaceutical or biotechnology industry or other related industry.

Preferred Experience : (none specified)

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.

Benefits

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.

Seniority Level

Mid?Senior level

Employment type

Full?time

Job function

Quality Assurance

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