Demo

Center Quality Manager I

Octapharma Plasma, Inc.
Milwaukie, OR Full Time
POSTED ON 4/2/2025
AVAILABLE BEFORE 6/2/2025

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!

Center Quality Manager I

This is What You’ll Do:

  • Operate independent of plasma center Operations to ensure compliance with all applicable federal, state, and local regulations, as well as industry standards (e.g., FDA, EMA).
  • Reports critical incidents and negative trends to plasma center Operations team and Regional Quality Director.
  • Collaborate with the plasma center Operations team to ensure product quality and donor safety.
  • Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
  • Execute QA policies and procedures to comply with regulatory requirements.
  • Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
  • Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.
  • Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
  • Ensure:
  • Quality Control (QC) checks and validation activities are performed in accordance with SOP.
  • Equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).
  • Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.
  • Prepare agenda and lead monthly Quality Assurance Meeting to discuss SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all donor center staff.
  • Serve as Designated QA Trainer.
  • Prepare for and lead internal and external audits and inspections.
  • Perform root cause analysis, implement corrective/preventive actions, and conduct effectiveness checks for systemic issues.
  • Continuously assess, promote, and improve the effectiveness of the quality systems in the plasma center through the investigation of trends resulting from failures in the execution of procedures.

This is What It Takes:

  • B.S. degree preferred. Other combinations of education and experience may be considered.
  • One (1) year experience in a Quality Assurance role required.
  • Demonstrated knowledge of FDA, EMA, ISO, and other regulatory standards applicable to plasma collection and handling required.
  • Experience with quality management systems (QMS) and quality control processes preferred.
  • Strong leadership and communication skills, with the ability to work effectively with cross-functional teams required.
  • Detail-oriented with excellent problem-solving and analytical skills required.
  • Demonstrated proficiency in office software.
  • Ability to work day and evening hours, weekends, holidays, and extended shifts.

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

This Is Why Nurses Love Working Here:

  • Excellent work/life balance
  • Home time is yours, so you can leave work at work
  • Centers operate limited hours during many major holidays
  • Excellent teamwork/friendly co-workers
  • Supportive environment
  • Strong ethical standards
  • Opportunities for advancement

Available for full time teammates (scheduled 30 hours per week):

  • Medical, Dental, Vision
  • Accident Protection Plan
  • Hospital Indemnity Plan
  • Legal Plan
  • Supplemental Life (employee, spouse, and child)
  • 401k

Octapharma Plasma, Inc. provides for full time teammates:

  • Basic Life and AD&D
  • Short- and Long-Term Disability
  • Two weeks of Paid Parental Leave (after one year of service)

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.

Our Benefits

Octapharma Plasma offers the following benefits for this full-time position:

Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in Octapharma Plasma's 401(k) Savings Plan; 15 days of Paid Time Off (PTO) and paid observed holidays as designated by the Company.

Working at Octapharma Plasma

We aspire to create a culture in which our employees feel inspired. You may be motivated to connect with donors, lead donation centers to new heights of excellence, or provide ideas and vision at a corporate level. We welcome you to consider all possibilities and see what positions best fit your interests and talents. Join the Octapharma Plasma team

With donation centers and team members throughout the U.S., Octapharma Plasma is growing at an impressive pace, and so is the positive impact of our work. Forming a diverse, inclusive, and collaborative community, Octapharma Plasma offers ways to enhance your life, career, and sense of professional accomplishment to everyone who joins our family.

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.

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