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Qa engineer • coral springs fl
QA Specialist II-Manufacturing Oversight
ADMA BiologicsBoca Raton, Florida, United States- Promoted
- New!
QA Tester - Boca Raton, FL (Onsite)
The Timberline Group CompanyBoca Raton, FL, United States- Promoted
- New!
System Engineer
TTG Talent SolutionsCoral Springs, Florida, USEngineer
GPACBoca Raton, FL, US- Promoted
Electrical Engineer
Globaltech, Inc.Boca Raton, FL, US- Promoted
- New!
QA Engineer - SDET
QDStaffBoca Raton, FL, United States- Promoted
Specialist QA I - Manufacturing Oversight
ADMA BIOMANUFACTURING LLCBoca Raton, FL, USQA Automation EngineerGravity IT Resources
Gravity IT ResourcesMorrisville, Florida- Promoted
- New!
QA Automation Analyst
Flybridge StaffingBoca Raton, FL, United States- Promoted
- New!
UI Engineer
DataAnnotationBoca Raton, FL, United States- Promoted
- Promoted
QA Engineer
VirtualVocationsTamarac, Florida, United States- Promoted
Manufacturing Engineer
Decimal Engineering - Join Our Team!Coral Springs, FL, US- Promoted
Manufacturing Engineer
PaychexCoral Springs, FL, US- Promoted
- New!
Electrical Engineer
ZipRecruiterBoca Raton, FL, United States- Promoted
Project Engineer
Malcolm DrillingPompano Beach, FL, US- Promoted
IT QA Manager
Cinch Home Services, Inc.Boca Raton, FL, USQA Analyst
InterSourcesBoca Raton, FL, US- Promoted
Principal Engineer / Senior Principal Engineer
Hazen and SawyerBoca Raton, FL, US- Promoted
Software Engineer
RoktBoca Raton, FL, US- pediatric dentist (from $ 33,540 to $ 310,000 year)
- electrical engineering (from $ 93,375 to $ 245,000 year)
- chief medical officer (from $ 60,000 to $ 237,500 year)
- public health dentist (from $ 192,428 to $ 234,000 year)
- radiologist (from $ 25,000 to $ 234,000 year)
- medical director (from $ 81,900 to $ 230,000 year)
- design director (from $ 163,400 to $ 227,975 year)
- consulting engineer (from $ 96,340 to $ 218,600 year)
- business development director (from $ 90,000 to $ 210,000 year)
- software development manager (from $ 132,500 to $ 205,400 year)
- Seattle, WA (from $ 97,500 to $ 167,500 year)
- San Jose, CA (from $ 98,855 to $ 165,000 year)
- San Francisco, CA (from $ 100,000 to $ 160,875 year)
- New York, NY (from $ 95,000 to $ 145,393 year)
- Boston, MA (from $ 100,643 to $ 145,000 year)
- Los Angeles, CA (from $ 92,471 to $ 143,520 year)
- Phoenix, AZ (from $ 91,250 to $ 143,520 year)
- Orange, CA (from $ 95,000 to $ 138,832 year)
- Chicago, IL (from $ 95,000 to $ 136,500 year)
- Atlanta, GA (from $ 93,850 to $ 136,500 year)
The average salary range is between $ 87,500 and $ 133,052 year , with the average salary hovering around $ 102,477 year .
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QA Specialist II-Manufacturing Oversight
ADMA BiologicsBoca Raton, Florida, United States- Full-time
Job DetailsLevel ExperiencedJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeTravel Percentage NoneJob Shift DayJob Category PharmaceuticalDescription
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 QA Specialist II-Manufacturing Oversight in Boca Raton, FL!
The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.
Qualifications
ESSENTIALS OF THE JOB :
- Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Deviation Reports.
- Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Perform general oversight of Buildings 1 and 2 (including cold rooms / freezers) and their associated activities, as required.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Review and release of raw materials in LIMS / SAP.
- Perform audits of Nitrogen receipt process.
- Perform notification and disposition of associated Lookback units.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.\
- Write, review, and revise QA SOPs.
- Review SOPs and documents from other departments and provide feedback as necessary.
- Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
- Assist with training of new employees.
- Rotation amongst QA Specialists to provide 24 / 7 manufacturing oversight coverage. Required to work 12 hour shifts (07 : 00 AM to 07 : 00 PM or 07 : 00 PM to 07 : 00 AM). Must be available to support coverage on either shift. Assist in other oversight activities, as needed
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP preferred.
EDUCATION REQUIREMENTS :
EXPERIENCE REQUIREMENTS :
3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.
In addition to competitive compensation, we offer a comprehensive benefits package including :
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, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees.
ADMA Biologics is an Equal Opportunity Employer.