Keysource Pharmaceuticals Jobs in Usa
1,680 positions found — Page 87
Summary:
All pharmacy technicians work under the direction of Clinical Pharmacists to provide pharmacy services with compassion, excellence, and efficiency.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Must be 18 years or older.
Operational Duties and Responsibilities
- Pharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.
- Prepares drug orders per physician request according to established policies, procedures, and protocols - Verifies computerized patient medication records accurately. Maintains, accurate, complete patient drug record. Compounds non-sterile pharmaceuticals. Provides services efficiently and in a timely fashion.
- Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.
- Verifies the daily activities of the department are complete and recorded.
- Maintains competency required for current job title/position
- Maintains current technician license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.
- Completes all competency/skills assessment requirements.
- Specialty area - Serves as the technician in specialty areas such as the operating room or pharmacy work areas outside the central pharmacy.
- Ambulatory care - Provides ambulatory pharmaceutical care services as assigned such as but not limited to anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.
- Retail - Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.
Clinical Duties and Responsibilities
- Ensures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.
- Reads, extracts, and interprets information in patient medical records accurately.
- Detects and reports suspected adverse drug reactions accurately and in a timely manner.
- Coordinates pharmacist drug education to patients and their families per institutional protocol.
- Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections, and maintains logs, records and other documentation as assigned.
- Provides services efficiently and in a timely fashion.
Occupational Hazards
- Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.
- Risk 0 exposure category.
- Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.
- Potential exposure to biologic material when participating in direct patient care activities (e.g., patient education, code attendance).
Job Requirements:
Education/Skills
- High School Diploma or equivalent preferred
Experience
- Pharmacy experience preferred
Licenses, Registrations, or Certifications
- Registered Pharmacy technician in the State of practice required
- Certified pharmacy technician preferred
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
MULTIPLE SHIFTS AVAILABLE
Work Type:
Full Time
Summary:
All pharmacy technicians work under the direction of Clinical Pharmacists to provide pharmacy services with compassion, excellence, and efficiency.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Must be 18 years or older.
Operational Duties and Responsibilities
- Pharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.
- Prepares drug orders per physician request according to established policies, procedures, and protocols - Verifies computerized patient medication records accurately. Maintains, accurate, complete patient drug record. Compounds non-sterile pharmaceuticals. Provides services efficiently and in a timely fashion.
- Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.
- Verifies the daily activities of the department are complete and recorded.
- Maintains competency required for current job title/position
- Maintains current technician license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.
- Completes all competency/skills assessment requirements.
- Specialty area - Serves as the technician in specialty areas such as the operating room or pharmacy work areas outside the central pharmacy.
- Ambulatory care - Provides ambulatory pharmaceutical care services as assigned such as but not limited to anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.
- Retail - Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.
Clinical Duties and Responsibilities
- Ensures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.
- Reads, extracts, and interprets information in patient medical records accurately.
- Detects and reports suspected adverse drug reactions accurately and in a timely manner.
- Coordinates pharmacist drug education to patients and their families per institutional protocol.
- Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections, and maintains logs, records and other documentation as assigned.
- Provides services efficiently and in a timely fashion.
Occupational Hazards
- Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.
- Risk 0 exposure category.
- Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.
- Potential exposure to biologic material when participating in direct patient care activities (e.g., patient education, code attendance).
Job Requirements:
Education/Skills
- High School Diploma or equivalent preferred
Experience
- Pharmacy experience preferred
Licenses, Registrations, or Certifications
- Registered Pharmacy technician in the State of practice required
- Certified pharmacy technician preferred
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
PRN
Work Type:
Per Diem As Needed
CHRISTUS Santa Rosa Hospital - Westover Hills (CSRH-WH) is a 150-bed hospital serving the fastest growing area of San Antonio. Specialized care includes orthopedic and surgical services, ICU, women’s services, a newborn nursery, comprehensive cardiovascular care from diagnostics to open heart surgery, vascular lab, sleep center, emergency services, the CHRISTUS Weight Loss Institute, wound care, rehabilitation, and more. The campus also boasts an Outpatient Imaging Center and three medical plazas, one of which houses our CHRISTUS Santa Rosa Family Medicine Residency Program and CHRISTUS Santa Rosa Family Health Center.
Summary:
All pharmacy technicians work under the direction of Clinical Pharmacists to provide pharmacy services with compassion, excellence and efficiency.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Must be 18 years or older.
- Pharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.
Operational Duties and Responsibilities
- Assist Pharmacists with Medication Histories.
- Train Tech I associates.
- Prepares drug orders per physician request according to established policies, procedures and protocols.
- Verifies computerized patient medication records accurately. Maintains, accurate, complete patient drug record.
- Compounds pharmaceuticals including non-sterile and sterile products, chemotherapy and parenteral nutrition products accurately.
- Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.
- Provides services efficiently and in a timely fashion.
- Verifies the daily activities of the department are complete and recorded.
- Maintains competency required for current job title/position
- Maintains current technician license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.
- Maintain IV certification and competencies.
- Completes all competency/skills assessment requirements.
- Specialty area
- Serves as the technician in specialty areas such as the operating room, IV room, or pharmacy work areas outside the central pharmacy.
- Ambulatory care
- Provides ambulatory pharmaceutical care services as assigned such as but not limited to: anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.
- Retail
- Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.
Clinical Duties and Responsibilities
- Ensures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.
- Reads, extracts and interprets information in patient medical records accurately.
- Detects and reports suspected adverse drug reactions accurately and in a timely manner.
- Sustains the hospital drug formulary, minimizing non-formulary procurements, utilizing therapeutic substitution protocols and promoting rational drug therapy selection.
- Provides accurate, adequate and timely drug information to the hospital’s pharmacy associates.
- Coordinates pharmacist drug education to patients and their families per institutional protocol.
- Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections and maintains logs, records and other documentation as assigned.
- Conducts designated interventions as defined in department Clinical Intervention activities (IV to PO, Renal Dosing, Pharmacokinetic dosing support, Anticoagulation)
- Baseline departmental standards for reporting interventions for clinical productivity as defined by departmental goals.
- Provides services efficiently and in a timely fashion
Occupational Hazards
- Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.
- Risk 0 exposure category.
- Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used. Potential exposure to biologic material when participating in direct patient care activities (e.g. patient education, code attendance).
Job Requirements:
Education/Skills
- High School Diploma or equivalent preferred
Experience
- 3-5 years of pharmacy technician experience preferred
- Meet all criteria of Pharmacy Technician I
Licenses, Registrations, or Certifications
- Registered Pharmacy Technician in the state of practice required
- Certified Pharmacy Technician preferred
- ACPE accredited IV certification program, including hazardous (minimum 40 hours); or meet minimum State requirement. Not applicable to Ambulatory Care settings or Retail settings
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
4 Days - 10 Hours
Work Type:
Full Time
Summary:All pharmacy technicians work under the direction of Clinical Pharmacists to provide pharmacy services with compassion, excellence, and efficiency.Responsibilities:
* Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.* Must be 18 years or older.
Operational Duties and Responsibilities
Pharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.
Prepares drug orders per physician request according to established policies, procedures, and protocols - Verifies computerized patient medication records accurately. Maintains, accurate, complete patient drug record. Compounds non-sterile pharmaceuticals. Provides services efficiently and in a timely fashion.
Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.
Verifies the daily activities of the department are complete and recorded.
Maintains competency required for current job title/position
Maintains current technician license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.
Completes all competency/skills assessment requirements.
Specialty area - Serves as the technician in specialty areas such as the operating room or pharmacy work areas outside the central pharmacy.
Ambulatory care - Provides ambulatory pharmaceutical care services as assigned such as but not limited to anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.
Retail - Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.
Clinical Duties and Responsibilities
Ensures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.
Reads, extracts, and interprets information in patient medical records accurately.
Detects and reports suspected adverse drug reactions accurately and in a timely manner.
Coordinates pharmacist drug education to patients and their families per institutional protocol.
Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections, and maintains logs, records and other documentation as assigned.
Provides services efficiently and in a timely fashion.
Occupational Hazards
Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.
Risk 0 exposure category.
Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.
Potential exposure to biologic material when participating in direct patient care activities (e.G., patient education, code attendance).
Job Requirements:
Education/Skills
* High School Diploma or equivalent preferred
Experience
* Pharmacy experience preferred
Licenses, Registrations, or Certifications
* Registered Pharmacy technician in the State of practice required* Certified pharmacy technician preferred
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
PRNWork Type:
Per Diem As Needed
Responsibilities:
* Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
* Must be 18 years or older.
* Pharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.
Operational Duties and Responsibilities
* Assist Pharmacists with Medication Histories.
* Train Tech I associates.
* Prepares drug orders per physician request according to established policies, procedures and protocols.
* Verifies computerized patient medication records accurately.
Maintains, accurate, complete patient drug record.
* Compounds pharmaceuticals including non-sterile and sterile products, chemotherapy and parenteral nutrition products accurately.
* Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.
* Provides services efficiently and in a timely fashion.
* Verifies the daily activities of the department are complete and recorded.
* Maintains competency required for current job title/position
* Maintains current technician license.
Ensures applicable CE records and licensure are maintained in department files.
Attends staff meetings.
* Maintain IV certification and competencies.
* Completes all competency/skills assessment requirements.
* Specialty area
* Serves as the technician in specialty areas such as the operating room, IV room, or pharmacy work areas outside the central pharmacy.
* Ambulatory care
* Provides ambulatory pharmaceutical care services as assigned such as but not limited to: anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.
* Retail
* Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.
Clinical Duties and Responsibilities
* Ensures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.
* Reads, extracts and interprets information in patient medical records accurately.
* Detects and reports suspected adverse drug reactions accurately and in a timely manner.
* Sustains the hospital drug formulary, minimizing non-formulary procurements, utilizing therapeutic substitution protocols and promoting rational drug therapy selection.
* Provides accurate, adequate and timely drug information to the hospital's pharmacy associates.
* Coordinates pharmacist drug education to patients and their families per institutional protocol.
* Participates in the quality improvement and medication use review activities of the department.
Collects data, conducts monitors and inspections and maintains logs, records and other documentation as assigned.
* Conducts designated interventions as defined in department Clinical Intervention activities (IV to PO, Renal Dosing, Pharmacokinetic dosing support, Anticoagulation)
* Baseline departmental standards for reporting interventions for clinical productivity as defined by departmental goals.
* Provides services efficiently and in a timely fashion Occupational Hazards
* Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.
* Risk 0 exposure category.
* Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.
Potential exposure to biologic material when participating in direct patient care activities (e.g.
patient education, code attendance).
Job Requirements: Education/Skills
* High School Diploma or equivalent preferred Experience
* 3-5 years of pharmacy technician experience preferred
* Meet all criteria of Pharmacy Technician I Licenses, Registrations, or Certifications
* Registered Pharmacy Technician in the state of practice required
* Certified Pharmacy Technician preferred
* ACPE accredited IV certification program, including hazardous (minimum 40 hours); or meet minimum State requirement.
Not applicable to Ambulatory Care settings or Retail settings In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule: 5 Days
- 8 Hours Work Type: Full Time
All pharmacy technicians work under the direction of Clinical Pharmacists to provide pharmacy services with compassion, excellence, and efficiency.
Responsibilities:
Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.Must be 18 years or older.Operational Duties and ResponsibilitiesPharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.Prepares drug orders per physician request according to established policies, procedures, and protocols - Verifies computerized patient medication records accurately. Maintains, accurate, complete patient drug record. Compounds non-sterile pharmaceuticals. Provides services efficiently and in a timely fashion.Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.Verifies the daily activities of the department are complete and recorded.Maintains competency required for current job title/positionMaintains current technician license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.Completes all competency/skills assessment requirements.Specialty area - Serves as the technician in specialty areas such as the operating room or pharmacy work areas outside the central pharmacy.Ambulatory care - Provides ambulatory pharmaceutical care services as assigned such as but not limited to anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.Retail - Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.Clinical Duties and ResponsibilitiesEnsures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.Reads, extracts, and interprets information in patient medical records accurately.Detects and reports suspected adverse drug reactions accurately and in a timely manner.Coordinates pharmacist drug education to patients and their families per institutional protocol.Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections, and maintains logs, records and other documentation as assigned.Provides services efficiently and in a timely fashion.Occupational HazardsPotential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.Risk 0 exposure category.Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used.Potential exposure to biologic material when participating in direct patient care activities (e.g., patient education, code attendance).
Job Requirements:
Education/Skills
High School Diploma or equivalent preferredExperience
Pharmacy experience preferredLicenses, Registrations, or Certifications
Registered Pharmacy technician in the State of practice requiredCertified pharmacy technician preferred
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
MULTIPLE SHIFTS AVAILABLE
Work Type:
Part Time
Summary:
All pharmacy technicians work under the direction of Clinical Pharmacists to provide pharmacy services with compassion, excellence and efficiency.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Must be 18 years or older.
- Pharmacy Technicians perform ONLY non-judgmental technical duties under the direct supervision of a pharmacist.
Operational Duties and Responsibilities
- Assist Pharmacists with Medication Histories.
- Train Tech I associates.
- Prepares drug orders per physician request according to established policies, procedures and protocols.
- Verifies computerized patient medication records accurately. Maintains, accurate, complete patient drug record.
- Compounds pharmaceuticals including non-sterile and sterile products, chemotherapy and parenteral nutrition products accurately.
- Issues controlled substances to patient care areas and maintains records as required by law and institutional policies.
- Provides services efficiently and in a timely fashion.
- Verifies the daily activities of the department are complete and recorded.
- Maintains competency required for current job title/position
- Maintains current technician license. Ensures applicable CE records and licensure are maintained in department files. Attends staff meetings.
- Maintain IV certification and competencies.
- Completes all competency/skills assessment requirements.
- Specialty area
- Serves as the technician in specialty areas such as the operating room, IV room, or pharmacy work areas outside the central pharmacy.
- Ambulatory care
- Provides ambulatory pharmaceutical care services as assigned such as but not limited to: anticoagulation clinics, intensive medical home, transition of care, Discharge Medication reconciliation, etc.
- Retail
- Performs outpatient distributive functions related to entering prescriptions orders, selecting the correct medications for new and refilled prescription orders, and coordinates delivery of medications for patient pick-up or delivery.
Clinical Duties and Responsibilities
- Ensures safe, appropriate, cost-effective drug therapies for patients according to established policies, procedures, and protocols.
- Reads, extracts and interprets information in patient medical records accurately.
- Detects and reports suspected adverse drug reactions accurately and in a timely manner.
- Sustains the hospital drug formulary, minimizing non-formulary procurements, utilizing therapeutic substitution protocols and promoting rational drug therapy selection.
- Provides accurate, adequate and timely drug information to the hospital’s pharmacy associates.
- Coordinates pharmacist drug education to patients and their families per institutional protocol.
- Participates in the quality improvement and medication use review activities of the department. Collects data, conducts monitors and inspections and maintains logs, records and other documentation as assigned.
- Conducts designated interventions as defined in department Clinical Intervention activities (IV to PO, Renal Dosing, Pharmacokinetic dosing support, Anticoagulation)
- Baseline departmental standards for reporting interventions for clinical productivity as defined by departmental goals.
- Provides services efficiently and in a timely fashion
Occupational Hazards
- Potential for exposure to hazardous and toxic substances (including chemotherapeutic, cytotoxic drugs and cleaning solutions), sticks or cuts by needles and other sharp items.
- Risk 0 exposure category.
- Potential for musculoskeletal injuries if proper lifting and carrying techniques are not used. Potential exposure to biologic material when participating in direct patient care activities (e.g. patient education, code attendance).
Job Requirements:
Education/Skills
- High School Diploma or equivalent preferred
Experience
- 3-5 years of pharmacy technician experience preferred
- Meet all criteria of Pharmacy Technician I
Licenses, Registrations, or Certifications
- Registered Pharmacy Technician in the state of practice required
- Certified Pharmacy Technician preferred
- ACPE accredited IV certification program, including hazardous (minimum 40 hours); or meet minimum State requirement. Not applicable to Ambulatory Care settings or Retail settings
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
5 Days - 8 Hours
Work Type:
Full Time
POSITION SUMMARY:
The Director, Microbiology, is accountable for developing and overseeing the implementation of the Contamination Control Strategy including disinfectant efficacy, aseptic processes and techniques, and microbial method validations. The incumbent collaborates with multiple stakeholders to ensure the execution of contamination control policies across all functions.
Additional responsibilities include leading the day-to-day operations of the Microbiology Laboratory, setting the direction of the Microbiology Laboratory operations, and developing and overseeing environmental monitoring program.
PRINCIPAL DUTIES:
- Accountable for the implementation and lifecycle management of the Contamination Control Strategy.
- Conduct risk assessments and develop mitigation strategies to minimize the risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk.
- Lead the Sterility Assurance program including aseptic process simulations, drug product sterility testing, endotoxin, and bioburden testing, testing of utilities and environmental monitoring testing.
- Provide guidance on aseptic processing for all aseptic area personnel and apply best aseptic practices and associated international aseptic processing regulations. Promote the continuous improvement in aseptic technique culture/behavior.
- Provide technical support and Subject Matter Expert input for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation. Support problem-solving during testing and for unexpected test results, working collaboratively with all stakeholders and management as needed.
- Develop and perform aseptic training and operator qualification program.
- Direct the day-to-day Microbiology testing activities ensuring compliance with cGMP and safety regulations. Ensure that Microbiology staff are adequately trained and are performing tests per method procedures.
- Development and management of the Environmental Monitoring Program and disinfectant efficacy program.
- Perform EM trend analysis and evaluation of critical system data,
- Oversee and manage contract laboratories related to the microbiology lab.
- Support inspection readiness plans and interact with regulatory agencies during inspections on matters related to Contamination Control and Sterility Assurance.
QUALIFICATIONS:
- Substantial in a leadership role within the pharmaceutical or biotechnology industry.
- Strong knowledge of microbiological testing including drug product sterility, endotoxin, aseptic process simulations, and sterile manufacturing sterility investigations.
- Bachelor's degree or higher in Life Sciences, Microbiology, Chemistry, or a related field
- 8+ years of relevant experience in commercial biotechnology or pharmaceutical production environment.
- Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP and EP monographs for microbiology
Pharmaceutics International Inc (Pii), a Jabil company, has an immediate opening for a senior level Quality Control Microbiology Manager for our high volume CDMO site in Baltimore area Maryland!
- Relocation is available
- Sponsorship not available
- Competitive salary and benefits
How will you make an impact?
The Manager of Quality Control (QC) - Microbiology is responsible for overseeing the Quality Control strategies and operations, including but not limited to testing function in support of the development and testing services of Phase I-III and Commercial Microbiological testing and Environmental Monitoring functions. The QC Microbiology Manager assures compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Manager identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Manger keeps Head of Quality informed of all departmental activities and product-related events.
What will you do?
- Provides technical supervision and leadership of teams that are assigned to perform environmental monitoring, product release testing, routine, and non-routine microbiological testing.
- Collaborates with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations.
- Oversight and maintenance of quality control microbiological testing program (including sterility, bioburden, identifications and Environmental Monitoring, and outsourced test laboratories).
- Participates and carries out continuous quality improvements in the QC laboratory.
- Identifies and resolves internal quality control microbiological testing issues.
- Ensures compliance with cGMP and safety requirements within the QC microbiological laboratory.
- Schedules and provides technical oversight of microbiological testing performed internally and externally sourced supporting GMP manufacturing and pre-Clinical activities and studies.
- Participates in project specific, system, client, and vendor audits.
- Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Pii SOPs, formats, and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.)
- Writes and/or reviews SOPs pertaining to Quality Control microbiological operations, STM's (standard test methods), and qualification and stability protocols (if needed) to insure appropriate codification of GMP procedures.
- Ensures QC microbiological laboratories and facilities are always in an audit ready status.
- Serves as a back up to QC client rep in meetings for microbiological matters.
- Acts as technical QC microbiological SME in support of client needs and projects and during third party inspections/audits.
- Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
- Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported to achieve expectations; maintain effective and professional communication between all parties, including the customer.
- Identify, maintain, and report functional KPIs to site management.
- Perform other duties as assigned.
How will you get here?
Education:
- Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
Experience:
- 3-5 years of experience in a senior level department management role in commercial laboratory operations
- 10 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)
- Preferred 15+ years relevant work experience in Quality Control laboratories
- Experience in Analytical or Microbiological testing including Environmental Monitoring required
- Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.
- Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance's (US and EU).
- Must be a strategic thinker and thrive in fast paced, high volume environments
Knowledge, Skills, Abilities:
- Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.
- Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-min
- ded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
Physical Demands:
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
What can Jabil offer you?
Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:
- Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
- 401K Match
- Employee Stock Purchase Plan
- Paid Time Off
- Tuition Reimbursement
- Life, AD&D, and Disability Insurance
- Commuter Benefits
- Employee Assistance Program
- Pet Insurance
- Adoption Assistance
- Annual Merit Increases
- Community Volunteer Opportunities
Apply Today!
The pay range for this role is $103,100 - $185,600. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.
As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.
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Position Summary
The Hospital Account Specialist is responsible for hospital coverage of their assigned territory driving sales to ensure Company sales goals are achieved.
The position reports to the National Director of Field Sales or the Regional Sales Manager.
Key Responsibilities
- Consistently achieve sales objectives through utilization of Sotalol IV in hospital accounts throughout assigned territory
- Effectively manage the formulary process to ensure product acceptance and protocol implementation
- Communicate effectively with all hospital-based stakeholders, including electrophysiologists, pharmacists, nurses and administrators
- Proactively identify and build relationships with key decision makers in assigned territory
- Regularly communicate field intelligence to all pertinent AltaThera stakeholders to ensure organizational understanding of the marketplace
- Work collaboratively with corporate staff, the medical affairs team and other support staff
- Compliantly communicate balanced, accurate, and complete information on AltaThera products
Qualifications
- 3+ years of pharmaceutical sales experience, with 1+ recent years of sales experience exclusive to HOSPITAL SALES
- Direct experience being the key driver of hospital formulary acceptance of pharmaceutical products
- Ability to execute pertinent business-related travel throughout assigned territory, including regular overnight travel
- Must live within assigned geographic territory
- Bachelor’s degree and valid driver’s license required
- Cardiovascular experience is strongly preferred; electrophysiology experience a major plus
- Recent experience launching a product or implementing a protocol in the hospital setting
- Proven ability to drive results in a challenging and ambiguous market
- Ability to effectively execute total account selling, bringing together multiple stakeholders (i.e. Physician/Pharmacy/Nursing) to achieve unified customer buy-in and implementation
- Ability to articulate the overall product value proposition as relates to the hospital, the patient and the payer
- Deep understanding of cardiology drugs and/or devices
- Performance driven and accountable
- Entrepreneurial self-starter, while also possessing the ability to be a true team player