Reports To:

The Pharmacist in Charge (PIC) will report to CEO.

Job Overview:

The Pharmacist in Charge is responsible for knowing and interpreting the regulatory aspects of each state that the pharmacy is licensed in and implementing policy to stay in compliance. The PIC is also responsible for managing all staff pharmacists. The PIC works in partnership with the Production Manager and Logistics Manager to manager workflow to achieve ultimate pharmacy goals.

Responsibilities and Duties:

• Oversees manufacturing and logistics operations

• Reviews and updates manufacturing documentation associated with manufacturing areas

• Provides USP and/or cGMP job-related training for personnel in the manufacturing areas in conjunction with Training Coordinator

• Oversees formulation process

• Oversees compounding process

• Reviews batch records along with Production Manager for completeness

• Assists with quality and compliance related initiatives

• Provides manufacturing leadership to technicians and supervisors

• Assists with quality-related investigations as needed

• Performs deviation investigations related to assigned area of responsibility along with implementing corrective actions to prevent recurrence of such deviations

• Interacts with all supporting departments (ex: Quality Assurance, Facilities/Engineering. Etc.) to ensure production deviations, change control, and any non-conformance are dealt with promptly and with appropriate quality considerations

• Revises, creates, and ensure compliance with SOP regarding process changes, regulatory guidelines, or as needed

• Effectively problem solves issues around sterile manufacturing

• Sets the standard for rigorous adherence to high work ethic, productivity, and commitment by exemplifying these traits and leading by example to the compounding staff

• Directly oversees the actively supervises non-sterile and sterile compounding operations ensuring compliance with standard operating procedures, USP, FDA, and DEA regulations

• Review labels for accuracy (if require on SOP)

• Release compounded products into Finished Good after acceptable review by QA

• Maintain compounding schedule with Production Manager

• Support and enforce company policies, practices, and cGMPs

• Assist in quality assurance and quality control when it applies to the compounding lab, including but limited to performing product recalls, evaluation of compounding technique, and supervising/performing in-process quality control on compound products

• Ensures safe, timely, efficient, compliant, and productive workflows in the operational and logistics areas in the areas of oversight

• Lead the planning and implementation of new services, initiatives, scholarships, and/or staff development

• Responsible for the direct supervision of the combination of pharmacy technician pharmacy interns, pharmacists, or support staff who work within their scope of clinical responsibility

• Supervises the dispensing and compounding staff in partnership with the Production Manager

• Stays current with regulations as they relate to pharmacy practice

• Responsible for leading and preparing for any inspections by regulatory authorities including but not limited to (Oklahoma Board of Pharmacy, FDA, DEA, NABP)

• Ensures compliance of Policy and Procedures with regards to SOPs

• Participates as a member of the Quality and Compliance Teams

• Participates in regularly scheduled meetings with management and engages in regular, direct communication with leadership on changing policies and overall facility progress

• Monitors performance and efficiency metrics by gathering relevant data and producing statistical reports KPIs with assistance of Production and Logistics managers

• In charge of Monthly state reports (as required) and any reports necessary for regulatory authorities

• Assists the Production and Logistics managers as well as the HR department with annual employee reviews and any disciplinary situations

• Answers questions from fellow pharmacists in a timely manner with a priority on researching the answers

• Strong leadership, training, and team-building skills

• Direct involvement in strategic planning and actively engages in decision-making.

• Ability to present and communicate successfully with all levels across the organization which requires excellent presentation, verbal, and written communication skill

• Hold staff accountable

• Serve as the liaison to coordinate compliance and regulatory issues for areas of responsibility.

• Maintain expertise in the selection and use of quality improvement methodologies/tools to maximize project outcomes.

• Develop and maintain expertise in change management tools and theories.

• Serve as a preceptor and/or advisor for pharmacy interns.

Qualifications:

• Must be able to cope with varied levels of workload and multiple tasks

• Must be able to work in a fast paced and changing environment

• Accurate data entry skills

• Strong time management and organizational skills

• Excellent communication skills, both orally and in writing

• Willingness to be a team player and promote a positive team environment

• Excellent attention to detail

• Flexible and proactive to meet varied patient and company needs

• Self-motivated and able to work independently

• Strong interpersonal and people skills

• Must be able to remain standing for entire shift

• Must be able to enter the cleanroom (become gown qualified) and be exposed to abrasive cleaning/disinfecting agents

• Must be able to work around hazardous and non-hazardous chemicals

• Maintain licensure in states as required

• Knowledge of state laws and federal regulations pertaining to 503B laws

• Analyze data and use this data to make appropriate decisions

• Ability to work in complex team environment and to collaborate with both external and internal professionals and other customers

• Computer skills – work processing, spreadsheets, pharmacy software, and databases.

• Ability to demonstrate skill sin prioritization, problem-solving, team building, collaboration, conflict resolution, decision making, time management, and strategic planning

• Knowledge of healthcare information systems and pharmacy automation and technology

• Demonstrates creativity and flexibility

• Ability to operate in high-pressure situations

• Ability to provide effective feedback

• Ability to write detailed policies and procedures and Investigational Reviews as needed

• Effective organizational, planning, and project management abilities

• Ability to function independently and deal with multiple, simultaneous projects

• Ability to demonstrate a commitment to quality and excellence

• 10 year minimum in industry

• Must be licensed in states required for 503B’s licensing

• Must understand GMP

• Must adhere to GMP and FDA guidance as well as 21 CFR 210/211

Production Lab Technician Duties and Responsibilities:

Set up equipment. Follow SOP's Operate general production equipment such as auto claves, pumps, scales, particle monitors, etc. Prepare solutions. Perform aseptic techniques and cGMP procedures. Document and maintain activity records according to cGMP regulations. Perform environmental monitoring during aseptic procedures. Collect samples. Perform daily cleaning of sanitation laboratories and equipment. Perform other duties as assigned. 

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Production Lab Technician Requirements and Qualifications: 

• High School Diploma or Equivalent Required.
• Post-High School education in a production or laboratory environment is preferred but not required.
• Experience in a production laboratory environment highly preferred.
• Excellent manual dexterity.
• Strong attention to detail and respect for quality assurance is required.
• Basic math skills
• Basic computer skills.
• Basic knowledge of Outlook, Word, and Excel.

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Advancement for a Production Lab Technician will be based on the following:

• Years of experience.
• Skill and education.
• Testing or continued education.
• Quality of work
• Personal growth within the Operations Department.

Job Overview:

Quality assurance specialists are responsible for monitoring, inspecting, and

proposing measures to correct or improve a company's final products and processes in order to meet established quality standards

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Quality Assurance Associate Duties and Responsibilities:

• Issue technical documents

• Organize, control, and oversee all GMP records and SOPs

• Implement and ensure adherence to Quality document change control

procedures

• Review and provide input for change requests require for GMP documents and routes documents for review approval

• Assess overall compliance with protocols, SOPs, company policies, applicable regulations, updates, and ensure appropriate approval of Quality documents

• Audit management and hosting

• Audit observations remediation and responses to FDA 483s and warning letters

• Product/Batch release approval as needed

• Implementation of GMP training program

• Continuous quality improvement activities

• Review and approve production records, calibration records,

validations/protocols (equipment, method, cleaning, software, process, stability), investigations, document change request, vendor qualification, and pest control records

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Qualifications

• Must be able to cope with varied levels of workload and multiple tasks

• Must be able to work in a fast paced and changing environment

• Accurate data entry skills

• Strong time management and organizational skills

• Excellent communication skills, both orally and in writing

• Willingness to be a team player and promote a positive team environment

• Excellent attention to detail

• Flexible and proactive to meet varied patient and company needs

• Self-motivated and able to work independently

• Strong interpersonal and people skills

• Must be able to work around hazardous and non-hazardous chemicals

• Analyze data and use this data to make appropriate decisions

• Ability to work in complex team environment and to collaborate with both external and internal professionals and other customers

• Computer skills – work processing, spreadsheets, and databases.

• Demonstrates creativity and flexibility

• Ability to operate in high-pressure situations

• Ability to provide effective feedback

• Ability to function independently and deal with multiple, simultaneous projects

• Ability to demonstrate a commitment to quality and excellence