Corporate Auditor

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Corporate Auditor

Octapharma Plasma

icon Charlotte, NC, US, 28273

iconFull Time

icon18 April 2024

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How to Maximize

your opportunity to do rewarding work,

your future leadership potential,

and your career growth?

Join an industry leader.

[Become one, too!]

Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:

Corporate Auditor

Remote

This Is What You’ll Do:

  • Ensures facilities (Donor Centers, laboratory, distribution centers, and supplier/vendor) maintain compliance in all areas of Quality Assurance in relation to FDA, EU, AGES, CLIA, PPTA, OSHA, and other external regulatory and company Standard Operating Procedures (SOPs).
  • Audits information in donor record files, donor-related processing records, and manufacturing records to verify that documentation has appropriately occurred in accordance with the company SOPs/policies and other requirements.
  • Verifies that nonconforming product is disposed of properly.
    • All applicable lookbacks and deviations are performed correctly and in a timely manner.
    • Ensures proper documentation of these processes is performed.
  • Performs audits for self-assessment evaluation, monitoring records, and overall compliance related to the company quality systems or other quality requirements. 5. Ensures that all internal audits are performed in accordance with the audit schedule; ensures audits are accurate, correctly documented, and closed in a timely manner.
  • Supplier audits:
    • Understands regulatory requirements for all vendors listed as critical or key suppliers.
    • Develops audit agendas to challenge supplier compliance.
    • Hosts/performs supplier audit, when needed.
    • Reviews and offers feedback on the acceptability of supplier audit responses when applicable.
  • Evaluates audit responses from the auditing facility prior to writing an official response letter. a. Writes response letters to audit reports.
  • Conducts auditor training when needed.
  • Other duties as assigned by Company management.

This Is Who You Are:

  • A natural leader who displays strong character and integrity
  • An excellent communicator and presenter
  • A person committed to excellent customer service all day, every day
  • Outgoing, personable, energetic, and enthusiastic
  • Excited to teach, learn, and advance with a growing organization
  • Self-motivated and willing to assume the initiative
  • Attentive to every detail
  • Capable of thriving with little supervision

This Is What It Takes:

  • Bachelor’s degree highly preferred. In lieu of a bachelor’s degree, 5-7 years of relevant, required experience will be considered.
  • 1 year of auditing experience required.
  • Must have a minimum of one (1) year work experience in a Donor Center and a minimum of one (1) year of quality assurance experience in biologics. 
  • Must have a minimum of one year work experience in a donor center and a minimum of one year of quality assurance experience in biologics
  • Intermediate or above experience in PowerPoint and Excel.
  • Experience in e-learning software, preferred (e.g. Articulate).
  • Experience with Learning Management Systems, preferred.
  • Must possess excellent facilitation skills.
  • Experience in a regulated environment, preferred.
  • Required travel will be up to 75% and will include overnight travel.
  • Previous experience interacting with middle management, senior executive level and across department functional lines.
  • Must have Certified Quality Auditor (CQA) certification or must be willing to start the CQA  certification process within a year.

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.

  • Formal training
  • Outstanding plans for medical, dental, and vision insurance
  • Health savings account (HSA)
  • Employee assistance program (EAP)
  • Wellness program
  • 401 (k) 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.