ADMA BIOCENTERS are FDA-licensed facilities dedicated to the collection of human plasma from donors. Human plasma is used to make special medications to help treat and prevent infections in patients. We have an exciting opportunity for a Regional Quality Assurance Manager.
The Regional Quality Assurance Manager is responsible for monitoring the Quality Assurance activities in assigned donor centers. Ensures compliance with regulations and customer requirements. Manages ADMA BioCenters' vendor approval and consignee notification process. Assists Director of Quality Assurance with center quality audits, audit response preparation and other duties as assigned. Assists with the revision and review of controlled procedures and other documents.
Essentials Of The Job
Oversees center quality assurance functions.
Performs routine site visits to assigned donor centers to observe and assess center compliance with applicable SOPs and applicable regulations.
Supports the Company training goals through active participation in the development of training materials for SOPs or other training initiatives as determined by ADMA needs.
Provides assistance in ensuring adequate control of all SOPs and training materials.
Monitors reviews, and provides guidance to center QA and Operations management for investigating and developing and implementing corrective/preventive actions for Internal Investigation Reports (IIR's).
Ensures regulatory compliance as defined in government regulations.
Assists center QA and Operations management with drafting responses to external audit observations.
Qualifications
Job Requirements
Bachelor's Degree preferred but can be offset by applicable work experience
A minimum of five years experience in pharmaceutical or biotechnology industry or other related industry. Three to five years experience in FDA/CBER regulated industry desired. Previous experience in Quality Assurance required. Previous experience should demonstrate expertise in interpreting cGMPs, FDA regulations, SOP development, as well as an understanding of quality principles.
Detail oriented, and have knowledge of scientific, medical and regulatory terms.
Ability to use personal computer and software including word processing, spreadsheet and database.
Demonstrated organizational and coordination skills, with close attention to detail and accuracy.
Good inter-personal and oral communication skills to effectively train personnel.
Demonstrated good problem solving skills with minimal supervision.
Mathematical skills including the use of calculations involving fractions, decimals and percentages.
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
Paid Time Off (within the first year)
Tuition Assistance (after the first year)
ADMA BioCenters, 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 BioCenters is an Equal Opportunity Employer
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Biotechnology Research
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