- 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
- 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
- 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
- Ability to stand for prolonged periods of time
- May need to lift, up to 40 pounds
- Limited exposure to potentially hazardous substances
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Quality Pharmacist - Southlake, United States - FARMAKEIO OUTSOURCING
6 days ago
Description
Job Description
Job DescriptionAs 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 Director
Compensation:$48 hourly - varies based on experience
Responsibilities:Perform and/or coordinate completion of:
Work Environment: Climate-controlled office environment
Knowledge & Skills
Physical and Special Requirements:
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.
