Sterile Compounding Quality Manager

Optioncare; Springfield (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Option Care Health, Inc. is seeking a Sterile Compounding Quality Manager to support cleanroom quality standards and CSP processes across our national network.

You will monitor metrics, lead CAPA initiatives, and collaborate with field and corporate teams to ensure compliance with regulatory, accreditation, and industry standards. The role requires strong autonomy, sound judgement, and the ability to manage multiple priorities while guiding quality improvements in sterile compounding and

Responsibilities

• Provides expert field support on cleanroom quality questions and assists during urgent quality incidents.
• Maintains and reviews cleanroom quality systems and tools; provides reports and executive summaries.
• Coordinates with cleanroom facilities teams to schedule certifications and review reports.
• Monitors quality indicators and trends; develops proactive quality initiatives for sterile compouding.
• Generates quality improvement reports and pharmacy metrics from relevant data sources.
• Leads root cause investigations; develops CAPA plans with management and stakeholders.
• Performs quality visits to assess cleanroom conditions and communicates findings to leadership.
• Supports new cleanroom construction/remodels with quality guidance and SOP development.
• Maintains vendor relationships and provides field support during interventions.
• Assists in improving action plans from inspections and accreditation findings.

Job description

Extraordinary Careers. Endless Possibilities.

With the nation's largest home infusion provider, there is no limit to the growth of your career.

Option Care Health, Inc. is the largest independent home and alternate site infusion services provider in the United States. With over 8,000 team members including 5,000 clinicians, we work compassionately to elevate standards of care for patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the infusion care experience for patients, customers and team members.

Join a company that is taking action to develop an inclusive, respectful, engaging and rewarding culture for all team members. At Option Care Health your voice is heard, your work is valued, and you're empowered to grow. Cultivating a team with a variety of talents, backgrounds and perspectives makes us stronger, innovative, and more impactful. Our organization requires extraordinary people to provide extraordinary care, so we are investing in a culture that attracts, hires and retains the best and brightest talent in healthcare.

Job Description Summary:

Job Summary The Sterile Compounding Quality Manager will assist in supporting and maintaining cleanroom quality standards and sterile compounding processes to meet or exceed regulatory, accreditation, and quality requirements for all cleanrooms nationally. Serves as the primary quality resource for an assigned operating area, providing support to other areas as needed including after-hours and weekend support during urgent quality events. Responsible for monitoring, trending, and analyzing quality metrics, identifying risks, and implementing corrective and preventive actions. Evaluates and recommends process improvements to enhance the quality, consistency, compliance, and safety of compounded sterile preparations (CSPs). Collaborates with appropriate stakeholders to ensure organization adherence to current regulations, industry standards, and best practices for sterile compounding. Ability to independently with a high degree of autonomy, demonstrating sound judgement, initiative, and the ability to effectively manage multiple priorities while partnering with leadership and Cleanroom Help team to achieve quality, clinical and regulatory goals.

Job Description:

• Provides support to the field as a subject matter expert regarding all cleanroom quality related questions and provides assistance during urgent cleanroom quality incidents. Includes appropriate leadership to ensure field support and assisting in quality clinical decisions based on Option Care Health policy.


• Assist in the maintenance and review of various cleanroom quality systems and tools. Provide reporting and executive summaries routinely and as directed.


• Works closely with cleanroom facilities team, and local leadership to ensure certifications are scheduled appropriately, reports are reviewed, microbial monitoring maps are current, accurate, and aligned with regulatory and operational requirements.


• Review key performance indicators and quality systems/tools for trends and assist in the development of proactive and preventative initiatives to ensure quality for sterile compounding practices.


• Provides standard and ad-hoc reports on quality improvement activities and adherence to quality metrics as requested. Assists in providing pharmacy metrics and various reports using relevant data sources.


• Leads root cause investigations and identifies systemic risks and contributing factors. Develops, coordinates, and monitors corrective and preventive action (CAPA) plans with management and key stakeholders to ensure effective resolutions and continuous improvement.


• Performs quality visits to conduct assessments and provide training regarding cleanroom quality and to assess cleanroom conditions. Communicates findings and action plans to appropriate corporate and/or field management personnel, legal and accreditation personnel as needed.


• Supports new cleanroom construction and remodel initiatives by providing quality and clinical guidance. Collaborates with stakeholders to develop and implement appropriate procedures, workflows, and controls to ensure compliant and effective cleanroom processes.


• In conjunction with management builds and maintains relationships with vendors. Provides support when intervention is required with vendors to support field cleanroom quality.


• Assist in the development of action plans for improvement based on Board of Pharmacy or other agency inspections, accreditation findings or internal quality indicators, recommendation and guidelines.


• Assist in the development and maintenance of policies, procedures, and training materials pertaining to sterile compounding and cleanroom quality based on Option Care Health standards and Federal and State regulations.


• Partner with Clinical Education on creating tr.