Job Information
OctaPharma Plasma Center Quality Manager I in Orangeburg, South 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 as a:
CENTER QUALITY MANAGER I
This is What You’ll Do:
Regulatory Compliance and Quality Assurance:
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).
Report 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.
Ensure equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).
Ensure 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.
Training and Development:
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.
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.
Audits and Inspections:
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.
Continuous Improvement:
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.
This is Who You Are:
Part brand ambassador, part clinical technician
A person committed to excellent customer service all day, every day
Someone with positive energy, always willing to pitch in where needed
Understanding, patient, and genuinely authentic
Able to keep up in a fast-paced environment
Hungry to build a great career
Someone who leads without fear!
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 both day and evening hours, weekends, holidays, and extended shifts.
