Process Validation Associate
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 Process Validation Associate in Boca Raton, Florida!
The Process Validation Associate is responsible for collecting, analyzing and evaluating process data for the purpose of maintaining control over all aspects related to validation of the manufacturing process.Qualifications
- Implement various validation assessment procedures according to required validation protocols
- Executing test plans and strategies, working with project teams including Engineering, Quality Control, and Manufacturing
- Statistical analysis of process data using including trend analysis, confidence intervals, ANOVA, and linear regression
- Using statistical analysis to set process alert limits and identify “process drift” and support investigations
- Provide periodic reports summarizing production yields and key impurity trends
- Construct and maintain statistical database for IgG process trending program
- Support deviation management
- Managing with a work plan/milestone dates.
Minimum of a Bachelors degree required
Requires a minimum of 5 years of experience working in a pharmaceutical manufacturing or manufacturing support setting. Knowledge of statistical analysis methods. Technical writing skills required. Basic understanding of systems data management, database structures, and data flow.
Other Essentials Knowledge/Skills
Must possess excellent written and verbal communication skills. Proficient in using Microsoft office applications and statistical control software. Good analytical skills.
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.
Sits at desk and in meetings.
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. 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.