Quality Assurance Associate 1

Job Summary

Want to Expand
your career-development potential,
your ability to help donors and patients,
and your access to professional opportunities?

 
We’re growing fast.
[You can, too!]

There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Quality Assurance Associate 1

This is What You’ll Do

Lookbacks Focus:

• Responsible for completion of customer notifications (lookback notification and customer deviation reports), resulting from unsuitable test results and/or post-donation information (PDI).  Customer notifications also include reporting to regulatory agencies and assisting with the determination of the final disposition of the affected products.  The associate will:
  • Collect, compile, and review data.
  • Communicate with Donor Centers for required data.
  • Prepare, review, and submit customer lookback notifications, as required.
  • Reports Electronic Biological Product Deviation Reports (eBPDRs) to FDA.
  • Generate quarantine files to apply automated product holds in plasma storage warehouse.
  • Complete lookback notification peer reviews
• Initiates and investigates corporate deviations and their associated Corrective and Preventative Actions (CAPA). 
• Reviews and reports Donor Center process deviations to OPI customers.
• Documents and submits customer deviation reports.
• Manage customer complaint investigations and documentation related to warehouse shipping deliveries.
• Completes peer reviews for Customer Deviations.
• Collaborate with Corporate Validation department to investigate product temperature excursions, assess final product disposition, report, and document customer approval/denial of product shipment.
• Initiates Change Requests for SOP revisions, as assigned by manager.

This is What it Takes

• One (1) year of quality assurance experience preferred.
• High School Diploma required.  Bachelor’s degree preferred.
• A practical working knowledge of quality assurance is required.
• Knowledge of cGMP regulations is required with an emphasis on 21CFR 210, 211, and 600s.
• Knowledge of Lookback requirements is preferred on 21 CRF Part 600.
• Understanding of customer specifications to ensure compliance.
• Requires strong office software experience.
• Must be detailed-oriented, able to follow detailed instructions, possess excellent time management skills, well-organized, a self-starter and display a professional demeanor with a high focus on customer service activities / responsibilities.
• Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.
• Must be able to work as a team member, maintaining day-to-day activities, while being responsive to changing priorities.
• Excellent verbal communication skills required.
• For internal candidates:
• • No Recurring Major/Critical Deviations within the last 6 months. No Verbal warning in the last 6 months.
• No Written warnings or Final Written warnings in the last year. No Active Process 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 navigate the office environment safely, including stairs and elevators if applicable
• Ability to use assistive devices if needed for mobility or communication
• Ability to travel via automobile and / or plane up to 5%
• Occupational exposure or hazard to blood borne pathogens in certain facilities.

Do Satisfying Work. Earn Real Rewards and Benefits

We’re widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel.

• Formal training
• Outstanding plans for medical, dental, and vision insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition Reimbursement
• Employee assistance program (EAP)
• Wellness program
• 401k retirement plan
• Paid time off
• Company paid holidays
• Personal time