We offer opportunities to learn, grow, and make a real difference
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 firstname.lastname@example.org.
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
- 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
Full Time Monday thru Friday
Are you looking for a new opportunity? Would you be interested in working with a select team of professional, skilled pharmacists, technicians, and assistants in a PCAB accredited compounding-only pharmacy and retail store located in a brand-new facility in a modern business park in Federal Way?
If so, then Key Compounding Pharmacy may be the place for you and we invite you to consider joining us. You will be working with some of the nicest, most compassionate people you could ever meet and you will be working closely with the pharmacy and lab team on a daily basis. We are not a chain or a massive organization. We are privately owned, we work hard, but we also have fun.
At Key Compounding Pharmacy, we strive to practice our principles and values in everything we do.
We collaboratively work to achieve common goals using effective and open communication while demonstrating respect and support for everyone.
We believe in and are dedicated to providing compassionate customer service and high quality customized compounds and nutrients to enhance the lives of those we serve.
We behave and communicate with honesty and moral principle at all times.
We consistently create a harmonious and productive environment by working together, treating everyone with dignity and showing appreciation for everyone’s contribution.
We are looking for a Pharmacy Assistant that can be effective in our pharmacy, nutrition center and shipping department.
Be Proactive can be defined as “Taking control and making things happen rather than just adjusting to a situation or waiting for something to happen.”
KCP’s example of Be Proactive is “Instead of reacting to or worrying about conditions over which we have little or no control, we focus our time and energy on things we can control.”
How to Apply
E-mail a request for a Key Compounding Pharmacy employment application form to email@example.com or download a job application form.
Key Compounding Pharmacy will e-mail you the employment application form.
Print out the application form, complete it and sign it.
Please mail your completed and signed application along with your resume to:
Key Compounding Pharmacy
Attention: Deanna Simons
530 South 336th Street, Federal Way, WA 98003
Key Compounding Pharmacy is an equal opportunity employer.
Ability to provide exceptional customer service to patients, physicians, and co-workers.
Ability to handle multi-line phones and administrative tasks such as filing.
Be willing to perform other duties and tasks as assigned.
Must be motivated, a self-starter, and able to work independently or as a part of a team.
Minimum 1 Year customer service experience
Minimum 1 Year call center or medical reception experience
Let's Work Together
Key Compounding Pharmacy
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