Center Quality Manager 1

Octapharma•Charlotte, NC

About The Position

This role serves as a member of the plasma center management team. The position will ensure all activities and processes related to plasma collection, donor eligibility, and product quality comply with regulatory requirements, industry standards, and company policies.

Requirements

Bachelor’s degree preferred.
One (1) year experience in a Quality Assurance role.
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.

Nice To Haves

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

Responsibilities

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.