Job Information
OctaPharma Plasma Center Quality Manager I in Charlotte, North Carolina
Description
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
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:
octapharmaplasma.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.
