CAPS QC Coordinator- Process Control

3 weeks ago

Allentown, Pennsylvania, United States tapwage Full time
Overview

Central Admixture Pharmacy Services, Inc. (CAPS) is the nation's largest network of outsourcing admixture pharmacies. CAPS, a pioneer in the outsourcing of compounded sterile preparations was founded in 1991.

State-licensed and FDA-registered, CAPS pharmacies deliver solutions from more locations than any other national compounder.

CAPS provides both custom and standard solutions to hospital and outpatient providers from our 25 locations across the United States.

Making over 300,000 local deliveries annually, CAPS pharmacies operate 365 days a year to dispense labeled, patient-specific and anticipatory IV prescriptions to our health system pharmacy customers.

CAPS believes safety is job one. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry.

We perform environmental monitoring, regular process validations, and daily process sterility testing as part of our routine Continuous Quality Assessment and Improvement Program.

The CAPS service is focused on the daily admixing, dispensing, and delivery of a variety of CSPs.

CAPS uniquely trained and licensed pharmacy personnel compound a broad range of patient and non-patient specific CSPs embracing the latest compounding technology, including proprietary software for ordering prescriptions and barcode safety checks for automated and manual compounding processes.

Each CAPS pharmacy is managed by a pharmacist with well-established compounding expertise. These directors manage a team of licensed pharmacists and certified technicians trained on CAPS Standard Operating Procedures.

CAPS employs a QA team of chemists, microbiologists, and on-site quality assurance personnel who are accountable independently from the admixture staff.

Quality Assurance reports are provided to our clients on a quarterly basis.


Orders are sent via CAPSLink, a web-based proprietary ordering software that can manage both complex and patient-specific prescriptions like Parenteral Nutrition (PN) and anticipatory compounded (AC) non-patient-specific order requests.

CAPS ordering system can also interface with your pharmacy management software for convenience and broader custom service options.

Pharmacists review orders upon receipt and prepare your order using an automated compounding process and a bar coded manual-add-system (MAS) to verify ingredient accuracy.


CAPS mixes to order so you can be assured your order is freshly compounded and has maximum beyond use dating (BUD) when delivered.

CAPS has a variety of delivery options including same day and next day services.

Responsibilities

Position Summary:
Ensure site-specific compliance with CAPS Standard Operating Procedures (SOPs).

Responsibilities:
Essential Duties

  • Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.
  • 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
  • New staff training
  • Sterility tests, aseptic technique qualifications, and media fill process validations.
  • Perform Document review of anticipatory and as appropriate nonsterile to sterile compounding batch records:
  • Verify that raw materials meet specification limits
  • Verify accuracy of labeling
  • Perform final disposition of Batch
  • Verify that product test results meet specification limits
  • Verify that all documentation is complete
  • Document noncompliance and evaluate if further investigation is needed
  • Submit samples to the appropriate labs for chemical assay and microbial tests.
  • Track vendor equipment calibration and maintenance records and assess for deviations.
  • Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template.
  • Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions
  • Support Internal & External audits.
  • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
  • Participate in Director of Pharmacy's staff meetings

Expertise:
Knowledge & Skills

  • Knowledge of pharmacy operations and regulatory guidelines.
  • Ability to perform pharmacy calculations.
  • Responsibilities:
Other Duties

  • As assigned by immediate supervisor.
#ID

#LI

#EL

Target Based Range

$22.76-$28.45

Qualifications

Expertise:
Qualifications - Experience/Training/Education/Etc

Required:

  • B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)
  • Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science.
  • As assigned by Supervisor.

Desired:

  • Minimum of 2 years experience in pharmacy preparation.
  • Pharmacy Technician Certification.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Additional Information

Responsibilities:

Other Duties:


The preceding functions have been provided as examples of the types of work performed by employees assigned to this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required.

Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.


Physical Demands:

  • Some travel may be required.
  • Ability to stand and/or sit for long periods of time.
  • Ability to reach, grasps, stoop, pull and perform repetitive motion procedures.
  • Ability to lift up to 20 lbs.


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

  • Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.


The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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