Quality Assurance Associate 1

About the role

Want to expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? Octapharma Plasma is growing fast and creating great learning and career development opportunities throughout the company, especially in our donation centers.

Responsibilities

• Complete customer notifications, including lookback notifications and customer deviation reports, resulting from unsuitable test results and/or post-donation information (PDI).
• Report customer notifications to regulatory agencies and assist with determining the final disposition of affected products.
• Collect, compile, and review data.
• Communicate with Donor Centers to obtain required information and documentation.
• Prepare, review, and submit customer lookback notifications as required.
• Submit Electronic Biological Product Deviation Reports (eBPDRs) to the FDA.
• Generate quarantine files to apply automated product holds in the plasma storage warehouse.
• Complete peer reviews of lookback notifications.
• Initiate and investigate corporate deviations and associated Corrective and Preventive Actions (CAPA).
• Review and report Donor Center process deviations to OPI customers.
• Document and submit customer deviation reports.
• Manage customer complaint investigations and documentation related to warehouse shipping deliveries.
• Complete peer reviews for customer deviations.
• Collaborate with the Corporate Validation department to investigate product temperature excursions.
• Assess final product disposition and report and document customer approval or denial of product shipment.
• Initiate Change Requests for SOP revisions as assigned by the manager.
• Maintain tracking of records located at off-site locations.
• Process storage requests and ensure all records are received at off-site locations.
• Ensure document control procedures are continuously applied throughout the company.
• Update, generate, and distribute Tables of Contents (TOC) for documents.
• Initiate Change Requests for documents as assigned by the manager.
• Collaborate with Donor Centers to manage KwikTag errors.
• Support Donor Center, Corporate, Warehouse, and Lab audits and regulatory inspections by gathering required information and documentation.
• Serve as a designated trainer for Corporate Quality Assurance Associate I and Associate II roles.
• Perform other duties as assigned.

Requirements

• One (1) year of quality assurance experience preferred.
• High School Diploma required; Bachelor’s degree preferred.
• Practical working knowledge of quality assurance required.
• Knowledge of cGMP regulations required, with an emphasis on 21 CFR Parts 210, 211, and 600.
• Knowledge of Lookback requirements under 21 CFR Part 600 preferred.
• Understanding of customer specifications to ensure compliance.
• Strong proficiency with office software.
• Detail-oriented with the ability to follow detailed instructions.
• Excellent time management and organizational skills.
• Self-starter with a professional demeanor and strong customer service focus.
• Ability to consistently follow through and ensure primary job duties and responsibilities are current and up to date.
• Ability to monitor and communicate progress on daily tasks and responsibilities to management.
• Ability to work effectively as part of a team while responding to changing priorities.
• Excellent verbal communication skills required.

Internal Candidate Requirements

• No recurring major or critical deviations within the last six (6) months.
• No verbal warning within the last six (6) months.
• No written or final written warnings within the last year.
• No active Performance Improvement Plan (PIP).

Physical Requirements

• Position works in-office at the corporate location.
• Ability to sit for extended periods of time.
• Ability to use a computer and other office equipment.
• Ability to occasionally lift and carry up to 10 pounds.
• Ability to reach, bend, and stoop as necessary.
• Ability to communicate effectively, both verbally and in writing.
• Ability to focus and concentrate on tasks for extended periods.
• Ability to safely navigate the office environment, including stairs and elevators, if applicable.
• Ability to use assistive devices, if needed, for mobility or communication.
• Ability to travel by automobile and/or plane up to 5%.
• May have occupational exposure to bloodborne pathogens in certain facilities.