What are the responsibilities and job description for the QA Specialist II - Document Control position at Adma Biomanufacturing Llc?
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 undeserved 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 QA Specialist II Document Control!
The QA Specialist II Document Control performs a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements. Writes, revises, and processes cGMP documents such as: Standard Operations Procedures (SOPs), Forms, and Batch Records. May conduct investigations related to manufactured products.
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.
Education Requirements:
High School diploma required. Bachelors Degree preferred but can be offset by work experience.
Experience Requirements:
Three to five years experience in pharmaceutical or biotechnology industry or other related industry.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Dental Insurance, Life and Disability
- 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
- Shuttle to the Boca Tri-Rail station
ADMA Biologics, Inc. 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.
