Quality Pharmacist

Job Description

As part of the Quality Unit at FarmaKeio Outsourcing (FKO), the Quality Pharmacist assists the Quality Director in overseeing the accuracy and completeness of products manufactured at FKO by establishing/approving documentation and reviewing quality data throughout all units of FKO. This role is responsible for reporting and developing/reviewing documentation to verify proper Quality Management System implementation. The Quality Pharmacist provides direct oversight of the compounding of pharmaceutical products at FKO and shall be responsible for batch approval/rejection since regulations require compounding to be by or under the direct supervision of a licensed pharmacist.

Reports to: Quality DirectorCompensation:

$48 hourly - varies based on experienceResponsibilities:

Perform and/or coordinate completion of:

Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts

Collect environmental monitoring samples as necessary

Train new Quality Unit staff

Record sterility testing results, aseptic technique qualifications, and media fill process validations

Prepare/revise operating procedures and specifications

Review/approve routine change control requests as designated

Verify that raw materials meet specifications limits

Oversee control of product labeling/label accountability

Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments

Use incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues

Assist with root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations, and CAPA

Assist with the investigation of excursions in manufacturing or other related operations. Resolve the cause, impact on product quality, disposition, and corrective actions at the direction of the Quality Director

Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batches

Verify that product test results meet specification limits

Track vendor equipment calibration and maintenance records and assess for deviations

Assist the Quality Director with results of deviation and complaint investigations, quality-related events, causal analysis, corrective actions, and preventive actions

Maintain quality records (equipment calibration and maintenance, training, deviation, and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification)

Reciprocate Pharmacist License as necessary to comply with regulatory requirements

Qualifications:

BS Pharmacy or Pharm.D with registration in good standing and current pharmacist license in the state of Texas

Ability to work autonomously within established procedures and practices

Work Environment: Climate-controlled office environment

Knowledge & Skills

Working knowledge of Current Good Manufacturing Practices (cGMPs), FDA regulations (21 CFR Parts 210, 211), and ICH regulations

Effective communication skills, both written and verbal

Ability to act effectively as a member of a team to resolve problems

Good organizational and time management skills

Physical and Special Requirements:

Ability to stand for prolonged periods of time

May need to lift, up to 40 pounds

Limited exposure to potentially hazardous substances

About Company

FarmaKeio Outsourcing is an FDA-registered 503B outsourcing facility that manufactures patented hormone pellets in a sterile, controlled environment. Our pellets are formulated and developed by integrative medicine experts to be consistent and effective, while also reducing the risk of side effects and inconsistent dosing. Each pellet has been expertly designed to promote enhanced absorption, faster recovery, and consistent dosing throughout the treatment cycle. Our rigorous validation processes ensure that every single product achieves consistent potency and purity to help patients achieve optimal outcomes with every treatment.

Our positions are on On-Site Full-Time position in Southlake, TX. The hours are 8:30 am to 5:00 pm CST Monday through Friday.