Center Quality Manager I

Octapharma Plasma, Inc.; Brooklyn Park (MN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Formal training

Medical, dental, and vision insurance

Health savings account

Flexible spending account

Tuition Reimbursement

Employee assistance program

Wellness program

Paid time off

Personal time

Job summary

A leading plasma product company in Brooklyn Park is seeking a Center Quality Manager I to ensure compliance with regulations and oversee quality control processes. The role involves collaborating with operations teams, preparing for audits, and implementing corrective actions. Candidates should have a preferred B.S. degree and one year of experience in quality assurance, with strong leadership and communication skills necessary for this position. Competitive benefits offered.

Qualifications

• One year experience in a Quality Assurance role required.
• Demonstrated knowledge of FDA, EMA, ISO regulations required.
• Experience with quality management systems preferred.

Responsibilities

• Ensure compliance with regulations and industry standards.
• Collaborate with operations team for product quality and donor safety.
• Prepare and lead audits and inspections.

Skills

Leadership and communication skills

Detail-oriented

Problem-solving skills

Analytical skills

Knowledge of regulatory standards

Education

B.S. degree preferred

Tools

Office software proficiency

Job description

your ability to help donors and patients,

and your access to professional opportunities?

We’re growing fast.

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
• Paid time off
• 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:

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

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.