Center Quality Manager 1

Octapharma Plasma, Inc.; Kansas City (KS); Presencial; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Formal training

Health insurance

Health savings account

Flexible spending account

Tuition Reimbursement

Employee assistance program

Wellness program

401k retirement plan

Paid time off

Company paid holidays

Personal time

Descripción de la vacante

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to uphold compliance with FDA/EMA standards, lead QA activities, and oversee donor safety at the plasma center level. The role emphasizes audits, CAPAs, and staff training within a fast-growing company that values quality and continuous improvement.

The position requires a B.S. degree preferred and at least one year in a QA role, with a focus on QMS and quality control processes.

Formación

• B.S. degree preferred.
• One year of experience in a Quality Assurance role is required.
• Experience with quality management systems (QMS) and quality control processes is preferred.

Responsabilidades

• Operate independent of plasma center Operations to ensure compliance with regulations and industry standards.
• Maintain current knowledge of regulations affecting plasma collection and donor safety.
• Report critical incidents and negative trends to Operations team and Regional Quality Director.
• Collaborate with Operations to ensure product quality and donor safety.
• Monitor quality performance indicators, deviations, CAPAs, and complaints.
• Oversee QC processes including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for shipments and documents.
• Lead audits and inspections and develop audit responses.
• Maintain audit records and follow up on findings.
• Train Quality backup staff and Plasma Center Quality Manager I.
• Develop and deliver training on GMP, SOPs, and regulatory compliance.
• Carry out proficiency assessments and ensure SOP-driven SOP compliance.
• Maintain calibration documentation and perform root-cause analysis for issues.
• Promote continuous improvement in quality systems and monitor changes.
• Lead monthly Quality Assurance meetings and communicate minutes to staff.
• Assist in selecting and onboarding Quality Backup staff.

Conocimientos

Quality Assurance

Regulatory compliance

GMP knowledge

Educación

B.S. degree preferred

Descripción del empleo

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:

Center Quality Manager 1

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).
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• 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.
• Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.
• Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
• Execute QA policies and procedures to comply with regulatory requirements.
• Quality Control (QC) checks and validation activities are performed in accordance with SOP.
• Prepare for and lead internal and external audits and inspections.
• Develop and implement audit responses ensuring timely completion and adherence to quality standards.
• Maintain audit records and follow up on audit findings and corrective actions.
• Serve as Designated QA Trainer and responsible for training Quality backup staff and Plasma Center Quality Manager I.
• Develop and deliver training programs for staff on quality-related topics, including GMP (Good Manufacturing Practice), SOPs (Standard Operating Procedures), and regulatory compliance.
• Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.
• Equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).
• 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.
• Support the implementation of continuous improvement initiatives.
• Monitor the effectiveness of implemented changes and adjust strategies as necessary.
• 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.
• Participate in the selection process for the Quality Assurance Back-up role.
• Provide direction and oversight of Quality Back-up staff, ensuring required quality tasks are completed within required time frames.
• Perform other duties as assigned.

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.
• Experience with quality management systems (QMS) and quality control processes preferred.

Physical Requirements

• Ability to work day and evening hours, weekends, holidays, and extended shifts.
• Ability to sit or stand for extended periods for up to four (4) hours at a time.
• Ability to tug, lift, and pull up to thirty-five (35) pounds.
• Ability to bend, stoop or kneel.
• Ability to enter an environment with a temperature of -40°C for short periods of time.
• Occupational exposure to blood borne pathogens.
• Ability to view video display terminal less than 18" away from face for extended periods of time, up to four (4) hours at a time.
• Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for diagnostic tests.
• Ability to type and use basic computer skills.
• Ability to use assistive devices if needed for mobility or communication.

Do Satisfying Work. Earn Real Rewards And Benefits

• 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

Pay Transparency

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.