Patient Care America
CLEANROOM LEAD PHARMACIST/SUPERVISOR
Patient Care America, Pompano Beach, Florida, us, 33072
JOB SUMMARY:
The Cleanroom Lead Pharmacist/Supervisor is a registered, licensed pharmacist who is responsible for providing safe and appropriate pharmacy service to patients in accordance with the policies and procedures of the company, the state's professional standards, and other regulatory entities. The Cleanroom Lead/Supervisor works closely with the Cleanroom Technician Group Lead to monitor and direct the daily activities regarding the company's pharmacy services and alerts management to any issues which may unfavorably impact the ability to provide services. The Cleanroom Lead/Supervisor reviews and analyzes processes and works with the Cleanroom Technician Group Lead and the management team to streamline and improve workflow and processes-particularly with all aspects involving PCA's Sterile Compounding Processes.
QUALIFICATIONS:Graduate of an accredited school of pharmacy, licensed and in good standing with the Florida State Board of Pharmacy.Advanced knowledge of pharmacy principles and practices, especially regarding USP 797. Execution of "Best Practices" techniques in day-to-day work activities is essential.Flexibility and ability to work as part of a multi-disciplinary team.Self-directed with excellent time management skills and able to work independently, occasionally under stressful conditions.Minimum of two years' experience in a hospital, home infusion or long-term care pharmacy setting preferred and should possess a minimum of one to two years supervisory experience in at least one of these settings.Ability to effectively plan, prioritize and multitask; excellent organizational skills.Ability to effectively mentor, lead, and supervise pharmacy staff and to motivate staff to practice accepted pharmacy procedures and techniques.Exceptional analytical skills and ability to initiate and establish work processes that require preparation of reports or documents for further review or analysis.Ability to identify problems within the work routine and can source and partner with management staff to correct and facilitate work processes.Ability to learn and master industry specific software applications (i.e., Newleaf, DoseEdge, Parata, etc.)Excellent customer service skills.ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for operations of the pharmacy department to effectively manage the compounding, dispensing and shipping processes according to all regulatory requirements.As the Cleanroom Designated Person, they are to oversee cleanroom pharmacists, pharmacy technicians and pharmacy support staff to ensure safe medication compounding, cleaning and work environment. This includes all aspects of the cleanroom including the training and direct oversight of compounding personnel.
Selecting an acceptable and reliable source to obtain non-active pharmaceutical ingredients (API) components when they are not available via an FDA-registered facility.Monitoring and observing compounding activities and taking immediate corrective action if deficient practices are observed. This includes evaluating when individuals should be excluded from working in compounding areas based on the risk of contaminating the CSP and the environment.Ensuring that policies and procedures are fully implemented.Making or approving any change(s) or alternations(s) to policy and procedure.Reviewing and approving all policies and procedures initially and at least every 12 months to ensure they reflect current practices.Ensure that follow-up is carried out if problems, deviations, or errors are identified.Have a process that allows for special accommodations for personnel if the quality of the CSP is maintained and the environment will not be affected.Ensuring that each area related to CSP preparations meets classified air quality standards.Ensure ISO Class 5 areas are located, operated, maintained, monitored, and certified to have appropriate air quality.Review all certification records to ensure that the classified environment meets the minimum requirements of the current, enforceable version of USP
.Ensure that the organization has a formal, written quality assurance (QA) and quality control (QC) program.Have training, experience, responsibility, and authority in quality assurance.Reviews and documents the QA and QC program periodically.Reviews all complaints to determine whether the complaint indicates a potential quality problem with the CSP.Determines whether a compounded preparation is expected to retain its integrity or quality when temperature excursions occur when compared to USP
.Determines what the dynamic operating conditions are in the compounding area that reflect the largest number of personnel and highest complexity of compounding expected during routine operation
Supervise IV compounding activities/all technicians while actively compounding in the IV room including cleaning teams.As the Cleanroom Designated Person, responsible for overseeing a training program for compounded sterile preparations to ensure competency of the following personnel:
Personnel with direct oversight.Restocking & cleaning personnel.Personnel that perform in-process checks.Personnel that perform final verification.Personnel that dispensing CSPs.Personnel that Compound CSPs.Certifiers/contractors/inspectors/surveyors.Personnel that oversee compounding.
The oversight of the monitoring and maintenance of the Cleanroom (Ignition, certification, design and HVAC issues).Successfully complete Media Fill and Gloved Fingertip testing after initial training and on an annual basis. Moreover, work with the Cleanroom Specialist and Cleanroom Tech Group Lead to conduct staff testing.Successfully complete and aid in conducting the Aseptic Technique and bi-annual didactic exams.Adhere to stability and compatibility guidelines and quality control procedures.Assist in the shipping, receiving, and delivery of products as necessary.Work directly with management team to determine efficiency in processes/workflow and ensure technicians and Pharmacist Team are appropriately trained and completing all required tasks timely and appropriately.Handle and direct new lines of business as necessary (i.e., Bundled Medications)Direct staff productivity to ensure timely completion of duties within established policies and in accordance with Board of Pharmacy requirements.Follow established procedures for drug and supply procurement and assist in maintaining appropriate inventory levels and preferred product selection of drugs.Provide exceptional service to patients, internal and external customers and interact in a professional manner with all contacts.Accurately maintain all legally required records.Monitor and ensure the accuracy of the work of Pharmacists, Pharmacy Technicians and Support personnel.Work with team to manage the process for investigating, assessing and reporting medication-related incidents and equipment error and/or failures to the company QA/PI committee.Participate in Performance Improvement Quality Assurance activities, educational programs and departmental meetings.Assist management with development/revision of department Policies & Procedures.Work with the Senior Director of Pharmacy Operations to develop and maintain new/existing employee training materials, oversee all Technician Training (new hire and ongoing training/competencies), and assist with annual performance reviews.
STRENGTH REQUIREMENT:
Standingfor the better part of the day performing functions in a cleanroom environment; may require stooping, bending, reaching, pushing, pulling, shifting or carrying of objects of up to 30 lbs. May perform tasks of a repetitive nature; i.e., keyboarding, calculating, et. al. Has a moderate degree of control within the work environment.
BENEFITS:
Our company offers competitive pay, incentive programs, generous paid time off, paid holidays, health insurance, life insurance, wellness, retirement, educational assistance, career growth, and much, much more!!
You must be able to pass a drug, background screen and be eligible to work in the U.S.
The Cleanroom Lead Pharmacist/Supervisor is a registered, licensed pharmacist who is responsible for providing safe and appropriate pharmacy service to patients in accordance with the policies and procedures of the company, the state's professional standards, and other regulatory entities. The Cleanroom Lead/Supervisor works closely with the Cleanroom Technician Group Lead to monitor and direct the daily activities regarding the company's pharmacy services and alerts management to any issues which may unfavorably impact the ability to provide services. The Cleanroom Lead/Supervisor reviews and analyzes processes and works with the Cleanroom Technician Group Lead and the management team to streamline and improve workflow and processes-particularly with all aspects involving PCA's Sterile Compounding Processes.
QUALIFICATIONS:Graduate of an accredited school of pharmacy, licensed and in good standing with the Florida State Board of Pharmacy.Advanced knowledge of pharmacy principles and practices, especially regarding USP 797. Execution of "Best Practices" techniques in day-to-day work activities is essential.Flexibility and ability to work as part of a multi-disciplinary team.Self-directed with excellent time management skills and able to work independently, occasionally under stressful conditions.Minimum of two years' experience in a hospital, home infusion or long-term care pharmacy setting preferred and should possess a minimum of one to two years supervisory experience in at least one of these settings.Ability to effectively plan, prioritize and multitask; excellent organizational skills.Ability to effectively mentor, lead, and supervise pharmacy staff and to motivate staff to practice accepted pharmacy procedures and techniques.Exceptional analytical skills and ability to initiate and establish work processes that require preparation of reports or documents for further review or analysis.Ability to identify problems within the work routine and can source and partner with management staff to correct and facilitate work processes.Ability to learn and master industry specific software applications (i.e., Newleaf, DoseEdge, Parata, etc.)Excellent customer service skills.ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for operations of the pharmacy department to effectively manage the compounding, dispensing and shipping processes according to all regulatory requirements.As the Cleanroom Designated Person, they are to oversee cleanroom pharmacists, pharmacy technicians and pharmacy support staff to ensure safe medication compounding, cleaning and work environment. This includes all aspects of the cleanroom including the training and direct oversight of compounding personnel.
Selecting an acceptable and reliable source to obtain non-active pharmaceutical ingredients (API) components when they are not available via an FDA-registered facility.Monitoring and observing compounding activities and taking immediate corrective action if deficient practices are observed. This includes evaluating when individuals should be excluded from working in compounding areas based on the risk of contaminating the CSP and the environment.Ensuring that policies and procedures are fully implemented.Making or approving any change(s) or alternations(s) to policy and procedure.Reviewing and approving all policies and procedures initially and at least every 12 months to ensure they reflect current practices.Ensure that follow-up is carried out if problems, deviations, or errors are identified.Have a process that allows for special accommodations for personnel if the quality of the CSP is maintained and the environment will not be affected.Ensuring that each area related to CSP preparations meets classified air quality standards.Ensure ISO Class 5 areas are located, operated, maintained, monitored, and certified to have appropriate air quality.Review all certification records to ensure that the classified environment meets the minimum requirements of the current, enforceable version of USP
.Ensure that the organization has a formal, written quality assurance (QA) and quality control (QC) program.Have training, experience, responsibility, and authority in quality assurance.Reviews and documents the QA and QC program periodically.Reviews all complaints to determine whether the complaint indicates a potential quality problem with the CSP.Determines whether a compounded preparation is expected to retain its integrity or quality when temperature excursions occur when compared to USP
.Determines what the dynamic operating conditions are in the compounding area that reflect the largest number of personnel and highest complexity of compounding expected during routine operation
Supervise IV compounding activities/all technicians while actively compounding in the IV room including cleaning teams.As the Cleanroom Designated Person, responsible for overseeing a training program for compounded sterile preparations to ensure competency of the following personnel:
Personnel with direct oversight.Restocking & cleaning personnel.Personnel that perform in-process checks.Personnel that perform final verification.Personnel that dispensing CSPs.Personnel that Compound CSPs.Certifiers/contractors/inspectors/surveyors.Personnel that oversee compounding.
The oversight of the monitoring and maintenance of the Cleanroom (Ignition, certification, design and HVAC issues).Successfully complete Media Fill and Gloved Fingertip testing after initial training and on an annual basis. Moreover, work with the Cleanroom Specialist and Cleanroom Tech Group Lead to conduct staff testing.Successfully complete and aid in conducting the Aseptic Technique and bi-annual didactic exams.Adhere to stability and compatibility guidelines and quality control procedures.Assist in the shipping, receiving, and delivery of products as necessary.Work directly with management team to determine efficiency in processes/workflow and ensure technicians and Pharmacist Team are appropriately trained and completing all required tasks timely and appropriately.Handle and direct new lines of business as necessary (i.e., Bundled Medications)Direct staff productivity to ensure timely completion of duties within established policies and in accordance with Board of Pharmacy requirements.Follow established procedures for drug and supply procurement and assist in maintaining appropriate inventory levels and preferred product selection of drugs.Provide exceptional service to patients, internal and external customers and interact in a professional manner with all contacts.Accurately maintain all legally required records.Monitor and ensure the accuracy of the work of Pharmacists, Pharmacy Technicians and Support personnel.Work with team to manage the process for investigating, assessing and reporting medication-related incidents and equipment error and/or failures to the company QA/PI committee.Participate in Performance Improvement Quality Assurance activities, educational programs and departmental meetings.Assist management with development/revision of department Policies & Procedures.Work with the Senior Director of Pharmacy Operations to develop and maintain new/existing employee training materials, oversee all Technician Training (new hire and ongoing training/competencies), and assist with annual performance reviews.
STRENGTH REQUIREMENT:
Standingfor the better part of the day performing functions in a cleanroom environment; may require stooping, bending, reaching, pushing, pulling, shifting or carrying of objects of up to 30 lbs. May perform tasks of a repetitive nature; i.e., keyboarding, calculating, et. al. Has a moderate degree of control within the work environment.
BENEFITS:
Our company offers competitive pay, incentive programs, generous paid time off, paid holidays, health insurance, life insurance, wellness, retirement, educational assistance, career growth, and much, much more!!
You must be able to pass a drug, background screen and be eligible to work in the U.S.