Career Opportunities

QA/QC MANAGER

Full-Time

We are bringing a QA/QC manager onto our team of 32 professionals at Key Compounding Pharmacy in Federal Way, WA. We provide personalized medications to patients in Washington and across the nation. We have sterile, non-sterile, and hazardous compounding operations, all of which must be kept in compliance with multiple regulating agencies including USP, FDA, PCAB, and the Washington State Pharmacy Board. We do not manufacture (this is a craft industry) yet still must satisfy our diverse regulators that we are safe, high quality, and compound with maximum consistency. We are licensed as a 503A compounding pharmacy and have an excellent reputation as the oldest and largest compounding pharmacy in the NW. This is not a learning position. Yes, you may need to learn our products and organization, but when it comes to QA/QC, you are an expert and able to develop and sustain an effective program from the ground up. If you are interested in Key Compounding Pharmacy, you probably come from the medical, biotech, pharma, or food processing industries. If not, let us know how what you know fits within our industry.

If you think that this position is for you, please contact our HR Department at  deannas@keycompounding.com.

Here at Key Compounding Pharmacy, we believe that integrity and accountability are the foundation for a genuine and lasting relationship with our customers. Part of our commitment is working honestly and ethically with our patients, their doctor, our team, and partners.

We are a premium solution in the market the QA/QC Manager will be integral to making sure we maintain that position years into the future. We take pride in our expertly trained staff of licensed assistants, technicians and staff pharmacists that maintain our standard of excellence.

QA/QC Manager Responsibilities:

• Review/Perform the Daily Compliance Verification. Document results, and report results to the PIC
• Perform and/or coordinate completion of:

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

• Collect environmental monitoring samples as necessary
• Train new Quality Assurance 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
• Using incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues
• Lead root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations, and CAPA
• Direct the investigation of excursions in compounding or other related operations. Resolve the cause, impact on product quality, disposition and corrective actions
• Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batch
• Verify that product test results meet specification limits
• Track vendor equipment calibration and maintenance records and assess for deviations
• Document results of deviation and complaint investigations, 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)

Knowledge & Skills

• Working knowledge of the regulatory environment and able to adapt to new regulations.
• In-depth knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211), and ICH regulations
• Effective communication skills, both written and verbal
• Leadership skills and the ability to facilitate the work activities of others
• Ability to act effectively as a member of a team to resolve problems
• Good organizational and time management skills

Qualifications

• Preferred ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence or SQA Registered Quality Assurance Professional
• BS degree or greater and 10 years in medical, biotech, pharma, or food processing industries with FDA GMP environments including 5+ years of supervisory experience
• A self-directed individual who needs little direction but asks for help when needed