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:

Corporate Quality Assurance Associate I

This is What You’ll Do: 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 includes 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 notifications, as required. Reports Electronic Biological Product Deviation Reports (eBPDRs) to FDA. Participates in and/or supports Donor Center audits and regulatory inspections, as assigned. Collaborates on different projects including process improvements, within the department, as
directed by Manager. Manage and correct tagging errors in Kwiktag. Initiates and investigates corporate deviations and their associated Corrective and Preventative
Actions (CAPA). Reviews and reports Donor Center process deviations to OPI customers. Performs the following Document Management responsibilities. Manages documents within the Quality Management System. Create/Update Document Profiles for documents. Launches collaboration for SOP revisions. Edits and formats documents in collaboration.

This is What It Takes:

Two (2) years of quality assurance experience in the pharmaceutical/biopharmaceutical industry
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 relationship between customer specifications to ensure compliance. Requires strong personal computer, keyboarding and Microsoft Office Applications (Access,
Excel and Word) skills. 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.

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

 

 

 

More About Octapharma Plasma Inc. 

With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

 

Interested? Learn more online and apply now at:

 

 octapharmahiring.com

 And if you know someone else who’d be a great fit at Octapharma Plasma, Inc., please forward this posting along!

INNER SATISFACTION.

 

OUTSTANDING IMPACT.