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Description

A 503B Quality Control (QC) Pharmacist is responsible for ensuring the quality, safety, and efficacy of compounded sterile preparations (CSPs) in a 503B outsourcing facility. These facilities are registered with the U.S. Food and Drug Administration (FDA) and are authorized to compound drugs in bulk for distribution. The QC pharmacist’s role involves overseeing the testing, validation, and quality assurance processes required for compliance with federal regulations and facility standards.

Responsibilities

Quality Control Testing:

• Oversee the testing results of compounded sterile products to ensure they meet the required quality standards.
• Conduct visual inspection, sterility testing, endotoxin testing, potency testing, and other relevant analytical tests.
• Ensure all testing procedures adhere to USP <797>, USP <800>, and other applicable standards.

Documentation and Compliance:

• Review and maintain batch records, certificates of analysis (COAs), and test results.
• Ensure proper documentation of quality control activities, including deviations, investigations, and corrective actions.
• Assist with regulatory audits and inspections, ensuring that the facility is compliant with FDA, USP, and state pharmacy board regulations.

Validation and Qualification:

• Support or lead validation efforts for equipment, processes, and systems in the quality control lab.
• Participate in equipment qualification, method validation, and re-validation processes to ensure consistency and reliability in testing.
• Review and approve validation protocols and reports.

Risk Assessment and Continuous Improvement:

• Conduct risk assessments to identify potential quality issues related to compounding and manufacturing processes.
• Recommend and implement corrective and preventive actions (CAPA) for identified quality problems.
• Collaborate with other departments (compounding, production, and regulatory affairs) to improve overall product quality.

Training and Mentorship:

• Provide guidance and training to QC personnel, pharmacy technicians, and other staff regarding quality control procedures and regulations.
• Ensure the QC team is up to date on current Good Manufacturing Practices (cGMP), USP standards, and FDA guidelines.

Equipment and Facility Maintenance:

• Oversee environmental monitoring of the facility, ensuring conditions such as temperature, humidity, and sterility are maintained according to required standards.

Regulatory and Safety Oversight:

• Stay updated on new FDA regulations, USP guidelines, and other relevant industry standards.
• Implement and enforce safety protocols in the laboratory and production areas to ensure compliance with safety regulations.

Qualifications

Education: PharmD or BS in Pharmacy (Doctor of Pharmacy preferred).

Licensure: Current pharmacist licensure in the state of Texas.

Experience:

• At least 2-5 years of experience in sterile compounding, QC testing, or related pharmacy fields.
• Experience working in a 503B outsourcing facility, hospital pharmacy, or manufacturing setting preferred.

Knowledge:

• In-depth understanding of USP <797>, USP <800>, and other related pharmaceutical compounding standards.
• Familiarity with FDA regulations, cGMP, and quality assurance practices.

Skills:

• Strong analytical, problem-solving, and critical thinking abilities.
• Excellent attention to detail and organizational skills.
• Ability to work independently and as part of a team.
• Strong communication skills to interact with cross-functional teams, regulatory bodies, and management.

Work Environment:

• The job is typically performed in a sterile compounding facility or pharmaceutical lab setting.
• The role may require working with specialized equipment, chemicals, and materials in a regulated environment.

Key Competencies:

• Quality control and assurance.
• Regulatory compliance.
• Analytical testing and documentation.
• Risk management and corrective actions.
• Staff training and development.

Compensation

$120,000 – $135,000 yearly

Description

As a 503B Fulfillment Technician, you will be an integral part of our operations, ensuring that hormone pellets are shipped and received with the utmost care and accuracy. Your contributions will help ensure that our patients receive the medications they rely on in a timely and safe manner. You will be working closely with our team to maintain compliance with FDA regulations, track shipments, and ensure that all materials are properly handled.

Why Join Us:

• Make a Difference: Your role will directly impact patients’ lives, helping to deliver medications that contribute to their overall health and well-being.
• Supportive Environment: We value teamwork and collaboration, providing a positive and uplifting work environment where everyone’s contributions are appreciated.

This is an on-site position in Southlake, TX. Mon-Fri 8:30am-5:00pm

Responsibilities

Key Responsibilities:

• Shipping Receiving: Accurately process inbound and outbound shipments of hormone pellets, ensuring that all products are received, inspected, and documented in accordance with regulatory and safety standards.
• Inventory Management: Monitor and maintain appropriate stock levels, accurately record all inventory transactions, and perform regular stock audits to ensure product availability and prevent any discrepancies.
• Quality Assurance: Adhere to strict protocols to ensure that all products meet our high standards of quality, including checking for damages, expiration dates, and accuracy of product labeling.
• Documentation: Maintain clear, accurate, and up-to-date records of all shipments and received products, ensuring compliance with 503B guidelines and company policies.
• Collaboration: Work with team members to ensure the smooth and efficient operation of the fulfillment process, assisting in troubleshooting and resolving any issues that arise.
• Safety Compliance: Follow all safety procedures and regulatory guidelines, including proper handling of materials and adherence to FDA, cGMP, and other relevant standards.

Qualifications

• High school diploma or equivalent; a degree in a related field is a plus.
• Previous experience in fulfillment, shipping/receiving, or pharmaceutical compounding (preferably in a 503B setting) is highly desirable.
• Strong attention to detail, organizational skills, and the ability to handle multiple tasks in a fast-paced environment.
• Excellent communication skills, both written and verbal.
• Ability to work independently and as part of a team, with a positive and solutions-oriented mindset.
• Basic computer skills and familiarity with inventory management systems.
• A commitment to maintaining a safe, clean, and compliant work environment.

Compensation

$20 – $23 hourly

About FARMAKEIO OUTSOURCING

FarmaKeio Outsourcing is an FDA-registered 503B outsourcing facility that manufactures bioidentical hormone pellets in a clean, controlled environment. As a leader in the field of 503B pharmaceutical services, we focus on offering high-quality and timely compounded medications while adhering to strict regulatory expectations. We believe in the power of collaboration, integrity, and service to ensure that each patient receives the best care possible.

Description

Our Vision: Establish FarmaKeio as the premier industry leader and innovator for compounding pharmacies.

Our Mission: To create lifelong clients. Our vision and mission are implemented through staff that identify with and support us in this effort. The successful candidate can project a caring attitude in all communication – phone, email, in person – and is able to function in a multi-tasking environment that encourages creativity and independence. Our company is growing and has opportunities for advancement, and we encourage a long-term relationship with our employees. We are not a traditional company in that we function from a place of servant leadership, both personally and professionally. Our relationship with one another and with every client defines what we do.

Position Summary: Responsible for processing compounding paperwork, interacting with patients, compounding products, and maintaining the pharmacy work area and equipment.

This is a full-time position, Monday-Friday, on-site in Richardson, TX

Responsibilities

Include the following. Other duties may be assigned.

• Provide administrative support for company management as needed to effectively execute company activities
• Facilitate new prescription entries and ensure the production team has the required data to process
• Packaging and shipping orders
• Assisting with the management of shipping inventory
• Comply with all applicable federal and state pharmacy laws
• Interact politely and effectively with patients, practitioners, and others

Perform duties in compliance with SOPs and best practices, including as directed and appropriate:

• Contact patients regarding medical information, their prescriptions, and the need for refills
• Input patient and prescription information subject to pharmacist supervision and checking in compliance with state pharmacy law
• Receive and reduce to writing refill requests as appropriate
• Compound preparations accurately and efficiently
• Clean and maintain the compounding environment and equipment
• Check the records or compounded products of others
• Maintaining a clean and organized work area
• Assure prompt and positive action on all questions, concerns, and suggestions
• Assist with updates, edits, reviews, and additions to procedure documentation
• Provide suggestions to improve customer service, company systems, or processes
• Learn and be a demonstration of our Core Values and utilize our Operational Guidelines in everyday communication and decision-making

Qualifications

Minimum Qualifications:

• Certified technician in good standing in the state in which the pharmacy is located
• Experience in compounding pharmacy preferred but not required
• Note: supportive documentation of prior experience if applicable will be required

Compensation

$20 – $24 hourly

About FARMAKEIO RICHARDSON

FarmaKeio is an industry-leading custom compounding pharmacy serving practitioners and their patients. Known for our unwavering commitment to quality, cutting-edge technology, and expertise, FarmaKeio Custom Compounding prepares both sterile and non-sterile prescriptions, certain commercially available medications, and retail and express shipping options in select locations.

Description

We are seeking a highly skilled and detail-oriented 503B QC Chemist to join our team at FarmaKeio Outsourcing, an FDA-registered 503B outsourcing facility. The QC Chemist will be responsible for ensuring the quality, safety, and efficacy of compounded pharmaceuticals by performing a variety of testing and quality control activities. This role is critical in supporting compliance with cGMP (current Good Manufacturing Practices) and other regulatory requirements specific to the compounding industry.

Responsibilities

Quality Control Testing:

• Perform analytical testing of raw materials, in-process samples, and finished compounded products, including but not limited to potency, sterility, endotoxin levels, and stability.
• Ensure compliance with 503B FDA guidelines, USP standards, and internal SOPs (Standard Operating Procedures).

Documentation and Record Keeping:

• Review and maintain accurate records of test results, batch records, and other required documentation to ensure traceability and compliance.
• Prepare and review other regulatory documents for finished products.

Method Validation & Development:

• Assist in the development and validation of analytical methods for product testing, ensuring they meet all regulatory requirements.
• Evaluate new technologies and methods to enhance testing capabilities and improve quality control processes.

Compliance and Audits:

• Support internal and external audits, inspections, and investigations by providing necessary documentation and test results.
• Assist in reviewing and maintaining SOPs to ensure they align with current regulatory standards.

Troubleshooting and Investigation:

• Identify and troubleshoot issues related to testing, equipment, or products.
• Investigate and report any deviations or out-of-specification (OOS) results and assist in CAPA (Corrective and Preventive Action) processes.

Equipment Maintenance and Calibration:

• Oversee the calibration and maintenance of laboratory equipment and instrumentation to ensure accurate results.
• Perform routine troubleshooting and validation of laboratory instruments.

Cross-Department Collaboration:

• Work closely with Production, Quality, and Fulfillment teams to ensure alignment of product quality standards and testing requirements.

Safety and Cleanliness:

• Adhere to safety guidelines and maintain a clean and organized lab environment.
• Ensure compliance with safety standards for the handling of chemicals and hazardous materials.

Qualifications

Education:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Master’s degree or higher in a relevant field is a plus.

Experience:

• Minimum of 2-3 years of experience in a Quality Control or Analytical Chemistry role, preferably within a 503B pharmacy, pharmaceutical manufacturing, or related industry.
• Familiarity with USP, FDA 503B guidelines, and cGMP regulations.
• Experience with laboratory instrumentation.

Skills and Abilities:

• Strong analytical and problem-solving skills.
• Excellent attention to detail and accuracy in documentation.
• Proficient in using laboratory software and instrumentation.
• Strong communication skills (both written and verbal) and the ability to work effectively in a team environment.

Description

We are seeking a detail-oriented and customer-focused 503A Call Center Pharmacy Technician to join our team. This role involves handling inbound and outbound calls from patients, healthcare providers, and internal pharmacy staff, ensuring a seamless experience in prescription processing and medication fulfillment. The ideal candidate must possess strong communication skills, pharmacy knowledge, and the ability to work in a fast-paced environment while adhering to compliance and regulatory standards for 503A compounding pharmacies.

This is an on-site position in Richardson, TX. Monday through Friday

3-5 Available Roles

Responsibilities

Key Responsibilities:

• Handle incoming and outgoing calls related to prescription orders, refills, and patient inquiries.
• Verify and input prescription information accurately into the pharmacy system.
• Assist patients and healthcare providers with medication-related questions and provide clear, professional guidance.
• Work closely with pharmacists and compounding technicians to ensure timely and accurate prescription processing.
• Maintain a high level of accuracy when collecting and documenting patient information.
• Monitor order statuses, provide updates, and resolve any issues that may arise with prescriptions or shipments.
• Ensure compliance with all pharmacy laws, regulations, and company policies, particularly those governing 503A compounding pharmacies.
• Coordinate with billing teams as needed.
• Maintain patient confidentiality and adhere to HIPAA regulations.

Qualifications

Qualifications & Requirements:

• High school diploma or equivalent required; Associate’s degree or higher preferred.
• Must hold a valid Pharmacy Technician license.
• Minimum of 2-4 years of experience in a pharmacy, call center, or healthcare-related field.
• Experience in a 503A compounding pharmacy is highly desirable.
• Strong knowledge of pharmacy operations, prescription processing, and insurance billing.
• Excellent verbal and written communication skills.
• Proficiency in pharmacy software systems and Microsoft Office Suite.
• Strong organizational skills, attention to detail, and ability to multitask in a fast-paced environment.
• Customer-focused mindset with problem-solving abilities.
• Ability to work flexible hours, including weekends or evenings, if required.

Compensation

$19 – $24 hourly