CA Center Quality Manager 1

Octapharma

Sacramento, CA

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JOB DETAILS

LOCATION

Sacramento, CA

POSTED

30+ days ago

Job Summary

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: CA Center Quality Manager 1

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).

• 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.

This is What it Takes

• Bachelor’s degree preferred.

• One (1) year experience in a Quality Assurance role.

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

• 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.

• Proficiency in 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 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.

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 $73,100-$97,500-$121,900 with 11.5% bonus pontenal. 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.

Please be advised that, although we may not have an immediate requirement at this time, we are consistently interested in engaging with well-qualified candidates for future opportunities. If you are interested in exploring a career with Octapharma Plasma, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. We expect the application window to close within 60 days from the posting date. Please ensure all applications are submitted before the deadline.

About the Company

Octapharma

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