CA Center Quality Manager 1

Octapharma Plasma, Inc.; Visalia (CA); On-site; USD 76,000 - 127,000; Full time

Benefits offered by this job

Health insurance

401k retirement plan

Paid time off

Paid holidays

Tuition reimbursement

EAP

Job summary

Octapharma Plasma, Inc. is seeking a QA leader to join the plasma center management team. You will oversee donor screening, plasma collection QC, and product documentation to ensure compliance with regulatory standards and SOPs.

leadership in GMP training, CAPA implementation, and audit responses, while driving continuous quality improvements across operations. This role requires strong regulatory knowledge and cross-functional collaboration in a fast-paced clinical setting.

Qualifications

• High school diploma or equivalent.
• Bachelor’s degree preferred.
• One year of experience in a Quality Assurance role.
• Experience with quality management systems and quality control processes preferred.
• Knowledge of FDA, EMA, ISO and other regulatory standards.

Responsibilities

• Operate independently to ensure compliance with all regulations and standards.
• Identify, document, and report incidents and CAPA to mitigate risk.
• Oversee QC processes for donor screening, collection, storage, and shipping.
• Monitor quality performance indicators and lead QA meetings.
• Conduct final QA release of shipments and documents.
• Deliver GMP/SOP/compliance training and supervise QA staff.
• Prepare for internal and external audits and close corrective actions.
• Promote continuous improvement of quality systems.

Skills

Leadership

Regulatory knowledge

Quality assurance

Cross-functional collaboration

Problem solving

Quality metrics

Education

Bachelor's degree preferred

High school diploma or equivalent

Tools

Microsoft Office

Job 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!]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.

Job Summary

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!]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.

This Is 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).
• Proactively identify, document, and report critical incidents, deviations, complaints, and negative Quality trends to plasma center Operations team and leadership; ensure timely escalation, root cause analysis, and initiation of corrective and preventative actions (CAPA) to mitigate risk and maintain compliance.
• 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.
• 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.
• Prepare agendas and lead monthly Quality Assurance Meetings, to ensure regulatory and SOP changes are reviewed, documented, and communicated to all donor center staff.
• Perform other duties as assigned.

This Is What It Takes

Minimum Requirements

• High school diploma or equivalent.
• Bachelor’s degree preferred.
• One (1) year experience in a Quality Assurance role.
• Experience with quality management systems and quality control processes preferred.

Required Certifications, Licenses, And Registrations

• N/A

Knowledge, Skills, And Abilities

• Knowledge of FDA, EMA, ISO, and other regulatory standards applicable to plasma collection and handling.
• Strong leadership and communication skills, with the ability to work effectively with cross-functional teams.
• Detail-oriented with excellent problem-solving and analytical skills.
• Proficient in Microsoft Office software.

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 use a computer and other office equipment.
• Ability to focus and concentrate on tasks for extended periods.
• Ability to use assistive devices if needed for mobility or communication.
• Ability to navigate the office environment safely, including stairs and elevators (if applicable).
• Ability to travel up to 75% via airplane and vehicle (is applicable)
• 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

Pay Transparency

The expected base pay for this position at hiring is $76,100 -$101,400-$126,800 annuallywith a bonus potential of 11.5%. Please note this wage range reflects what Octapharma Plasma expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.

Our Benefits

Octapharma Plasma offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in Octapharma Plasma's 401(k) Savings Plan; 15 days of Paid Time Off (PTO) and paid observed holidays as designated by the Company.