Experience:
1-3 years of experience
Concerned about your lack of experience? Learn More...
Employment Type:
Part time
Posted:
9/21/2018
Job Category:
Health Care Provider
Industry:
Other
Quality Assurance Associate
(This job is no longer available)
Octapharma Plasma, Inc. | Charlotte, NC
loading
loading
School
Major
Grad Date
 
 

Not sure what types of jobs you are interested in?


Explore Jobs
Based on Your Education

Follow This Company
Share

Job Description

Quality Control – Regulatory

Job Responsibilities

We are seeking a Quality Assurance Associate to assist in supporting activities within Octapharma’s Corporate Quality Department. Reporting into the Manager of Corporate Quality, this position is responsible for the completion of Lookbacks, corporate deviation investigations, and assisting with the determination of the final disposition of affected products.

Additional responsibilities of the Quality Assurance Associate role include:

  • Collects, compiles, and reviews data
  • Communicates with Donor Centers for required data
  • Reports Electronic Biological Product Deviation Reports (eBPDRs) to FDA
  • Investigates and submits deviations to OPI customers
  • Participates in and/or supports Donor Center audits and regulatory inspections, as assigned
  • Collaborates on various projects including process improvements, within the department, as directed by Manager
  • Performs Document Management Specialist responsibilities part-time
Quality Control – Regulatory

Job Requirements

Ideally, candidates will have two years of quality assurance experience in the pharmaceutical/biopharmaceutical industry.  A High School Diploma is required, bachelor’s degree preferred.  You must offer strong organizational skills, attention to detail and excellent interpersonal skills.

Other requirements of the Quality Assurance Associate role include:

  • Knowledge of cGMP regulations
  • Understanding of relationship between customer specifications to ensure compliance
  • Requires strong skillset in keyboarding and Microsoft Office Applications (Excel and Word)
  • Must be able to follow detailed instructions, possess excellent time management skills, be a self-starter and display a professional demeanor
  • 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

     

Quality Control – Regulatory

About Octapharma Plasma, Inc.

We believe the growth and success of each of our employees is an important part of the continued growth and success of our company. We create a workplace known for teamwork and recognition based on the following values: Customer Focus Leadership Integrity Team Spirit Self Respect Respect for Others Life Balance Safety