Center Quality Manager 1

Octapharma Plasma, Inc.; Midfield (AL); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Formal training

Health savings account

401k retirement plan

Paid time off

Company paid holidays

Job summary

Octapharma Plasma, Inc. in Midfield, Alabama seeks a Quality Assurance professional to join the management team. This role involves ensuring compliance with regulatory requirements, overseeing quality control processes, and leading audits to sustain high standards in plasma collection. Candidates should have a B.S. degree and one year of QA experience.

Benefits include medical, dental, and vision plans, HSA, FSA, tuition reimbursement, 401k plan, and paid time off.

Qualifications

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

Responsibilities

• Ensure compliance with federal, state, local, and industry regulations.
• Oversee quality control processes for donor screening and plasma collection.
• Prepare and lead internal and external audits.

Skills

Quality Assurance

Quality Management Systems

Regulatory Compliance

Education

B.S. degree

Job description

Job Summary

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.

What You’ll Do

• Operate independently of plasma center operations to ensure compliance with all federal, state, local, and industry regulations (e.g., FDA, EMA).
• Report critical incidents and negative trends to the Operations team and Regional leadership and collaborate with Operations 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 requirements.
• Oversee quality control processes, including donor screening, plasma collection, storage, and shipping; ensure QC checks, validations, equipment calibration, and CLIA assessments are performed according to SOPs.
• Monitor and review quality performance indicators, including deviations, Corrective and Preventive Actions (CAPAs), and complaints; lead monthly Quality Assurance meetings to discuss SOP changes and regulatory requirements.
• Conduct final QA review and release of all product shipments and associated documents to ensure compliance with customer specifications.
• Serve as Designated QA Trainer, developing and delivering training on GMP, SOPs, and compliance; provide direction and oversight to quality backup staff and participate in QA staff selection.
• Prepare for and lead internal and external audits; maintain audit records and ensure timely completion of audit responses and corrective actions.
• Perform root cause analyses, implement CAPAs, and conduct effectiveness checks for systemic issues.
• Continuously assess, promote, and improve quality systems by investigating trends, supporting continuous improvement initiatives, and monitoring outcomes.
• Provide leadership in the implementation of changes, adjusting strategies as necessary to strengthen quality and compliance.
• Perform other duties as assigned.

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 sit or stand for extended periods.
• 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.
• Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for diagnostic tests.
• Ability to use a computer and other office equipment.
• Ability to use assistive devices if needed for mobility or communication.
• Ability to communicate effectively, both verbally and in writing.
• Ability to focus and concentrate on tasks for extended periods.
• Ability to navigate the office environment safely, including stairs and elevators (if applicable).
• Ability to travel up to 20% via airplane and vehicle for CQM I and up to 75% for all others.

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