Quality assurance specialist Jobs in USA

Job Description Header :

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 an BioCenter Quality Assurance Specialist.

Job Title : Specialist, Quality Assurance

Job Description : Position Summary

This position is responsible to ensure all center activities are performed in accordance with standard operating procedures (SOPs) and the center is ready for inspection by regulatory agencies at any time.

The Quality Assurance Specialist (QAS) assists in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed in an effort to reduce or eliminate the potential of errors. This may be identified through scheduled audits, performance observations, or record review.

This position assists in the gathering and compilation of data and information to provide appropriate monitoring of all quality initiatives and programs. The QAS is responsible for ensuring an appropriate investigation of any deviations from process or procedure is complete. The investigation may require root cause analysis and effective corrective or preventative actions. Monitoring for the recurrence or the potential for recurrence is a critical component of data analysis.

Essential Functions (ES) and Responsibilities

• Key Duties (E)

Assures the Plasma Center(s) is in compliance with all applicable state, federal, and European guidelines.

Job Responsibilities or Job Requirements

Competencies

Ability to follow the cGMP's and procedures with great attention to detail

Able to work in high-pressure, deadline-driven environment

Basic computer skills including experience with software programs such as Word, Excel, and GroupWise

Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines

Demonstrated ability to work well with people from diverse backgrounds

Exceptional organizational and communication skills required

Maintains competence with all position required tasks

Managing Time

Experience Requirements

Bachelor's degree or equivalent professional experience.

One minimum of one year of Quality Assurance experience in a Donor Center or similar Quality Assurance or medical field experience.

Preferred Experience

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.

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In addition to competitive compensation, we offer a comprehensive benefits package including : 401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA 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.