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:

Job Responsibilities (listed in order of importance and/or time spent)

• 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 training materials and tools for orientations and training programs as it relates to sterile compounding, clean room maintenance, and regulatory compliance.
• Responsible for building and maintaining relationships with team members across Option Care
• Support efforts to drive continuous cycles of improvement, innovation, opportunities for efficiency and standardization

Supervisory Responsibilities
Does this position have supervisory responsibilities?

(i.e. hiring, recommending/approving promotions and pay increases, scheduling, performance reviews, discipline, etc.)

No X

Basic Education and/or Experience Requirements

• Compounded Sterile Preparation Technician (CSPT) through the PTCB, OR
• Board Certified Sterile Compounding Pharmacist (BCSCP) through BPS.
• Pharmacy Technician licensure or registration as granted by home state, or active and unrestricted pharmacist license.
• 7 years of experience in infusion therapy, sterile compounding, training, creating presentations, creating forms and policies, or other equivalent corporate office environment.

Basic Qualifications

• Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
• At least 3 years of experience analyzing and reporting data to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Intermediate to upper intermediate user of Microsoft Outlook, Word, PowerPoint, and Excel.
• At least 3 years experience in identifying operational issues and recommending and implementing strategies to resolve problems.
• At least 3 years experience in direct or indirect management of team members, including assisting in the development, training and assignment of work/projects to other team members.
• At least 7 years of relevant pharmacy technician or pharmacist experience working in a home infusion pharmacy, or large sterile compounding cleanroom.

Physical Demand Requirements

• May be required to sit for extended periods of time.
• Ability to work on a laptop or personal computer for extended periods of time.
• Ability to enter a cleanroom in manner that does not compromise quality of sterile preparations.

Travel Requirements: (if required)

• Willing to travel up to 50% of the time for business purposes (within state and out of state).

Preferred Qualifications & Interests (PQIs)

• Experience evaluating information to determine compliance with standards, laws, and regulations.
• Active participation in professional organizations.

This job description is to be used as a guide for accomplishing Company and department objectives, and only covers the primary functions and responsibilities of the position. It is in no way to be construed as an all-encompassing list of duties.

Due to state pay transparency laws, the full range for the position is below:

Salary to be determined by the applicant's education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.

Pay Range is $99,971.35-$166,611.42

Benefits:

-Medical, Dental, & Vision Insurance

-Paid Time off

-Bonding Time Off

-401K Retirement Savings Plan with Company Match

-HSA Company Match

-Flexible Spending Accounts

-Tuition Reimbursement

-myFlexPay

-Family Support

-Mental Health Services

-Company Paid Life Insurance

-Award/Recognition Programs