Sr. Quality Data Analyst (Stability/Biological Statistics)
- Employer
- ADMA Biologics
- Location
- Boca Raton, FL
- Start date
- Sep 23, 2020
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
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Job Details
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 Senior Quality Data Analyst!
Sr Quality Data Analyst focuses on statistical analysis of biological products for
STABILITY program & LABORATORY trending:
Designs, conducts and implements training.
Qualifications
Responsibilities:
Education Requirements: Requires a Bachelor's or Masters' degree in Biology, Chemistry, Mathematics, or related scientific field. Must include statistics.
Experience Requirements: Requires at least 3-5 years of experience in a regulated laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc.) is required. Must be familiar with GLP and GMP guidelines. Working knowledge of trending and/or stability analysis in a regulated environment a plus.
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 is an Equal Opportunity Employer.
Sr Quality Data Analyst focuses on statistical analysis of biological products for
STABILITY program & LABORATORY trending:
- Stability Programming including managing, analysis, and reporting for product stability studies and laboratory trending reports. Leads the designs, conduct and implementation of Stability and Trending programs.
- Prepares/revises documentation such as SOPs, Stability Protocols, and Quality Systems reports, etc.
Designs, conducts and implements training.
Qualifications
Responsibilities:
- Performs, manages and has expertise in assigned areas of responsibility, which primarily includes providing QC functions, such as:
- Writes Interim and Final Stability data reports. Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.
- Writes and revises technical documentation for department areas of responsibility such as SOP's, Stability Protocols, Specifications, etc.
- Writes thorough change controls and investigations for quality systems.
- Trains to become a Qualified Appearance Inspector and performs Appearance inspections.
- Designs, implements and maintains analytical assay trending reports.
- Has expertise and guides others in cGMP and cGDP practices in documentation and execution of job functions.
- Ensures compliance with all regulatory requirements by verifying procedures are being followed, all record keeping is current, proper maintenance occurs and new requirements are identified as they arise.
- Interacts with others, both within and outside the department, to provide customer support on issues and inquiries related to QC department functions.
- Performs, reviews and trains on processes performed within the department.
- Assists in other functions, as assigned by the Manager. This may include Department areas of responsibility such as, customer supports functions for QC Laboratory, monitoring temperature-controlled chambers, etc.
Education Requirements: Requires a Bachelor's or Masters' degree in Biology, Chemistry, Mathematics, or related scientific field. Must include statistics.
Experience Requirements: Requires at least 3-5 years of experience in a regulated laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc.) is required. Must be familiar with GLP and GMP guidelines. Working knowledge of trending and/or stability analysis in a regulated environment a plus.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays and Personal Days
- 3 Weeks' Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Company paid shuttle to the Boca Tri-Rail station
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.
Company
ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
Company info
- Website
- http://www.admabiologics.com/
- Phone
- 201-478-5222
- Location
-
5800 Park of Commerce Blvd. NW
Boca Raton, FL 33487
US
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