CAPS Chemist I

B.Braun

Irvine, CA


Overview

About CAPS®

CAPS is the nation's largest network of outsourcing admixture pharmacies. A pioneer in the outsourcing of CSPs, CAPS was founded in 1991, and delivers high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities across the nation. CAPS has three 503B Outsourcing Facilities that are registered with the FDA to provide anticipatory compounding services. CAPS also has 22 state licensed 503A regional pharmacies that dispense labeled, patient-specific prescriptions. To learn more, visit www.capspharmacy.com.

 

Responsibilities

Position Summary:

The Chemist I is responsible for performing instrument qualifications, analytical methods validation, and stability validation for new and existing pharmaceutical products. This position is responsible for performing independent tasks of great complexity with limited guidance from senior personnel, demonstrate high problem solving skills and developing, implementing and managing projects.  This position is also responsible for routine CAPS’ raw material and finished product sampling and testing and other routine functions as required by CAPS.

 

 

Responsibilities: Essential Duties

  • Review, write, and execute validation and stability protocols for new and existing pharmaceutical products in accordance with USP or FDA guidelines.
  • Perform analytical methods validation and instrument qualifications.
  • May represent department in contacts with regulatory agencies, including interfacing with FDA investigators.
  • Perform routine HPLC or other chemistry analysis of finished products, raw materials, stability and CAPS samples according to established specifications and procedure using various laboratory apparatus.
  • Interpret and apply specifications and operating procedures when carrying out both monitoring and testing responsibilities.
  • Record data in controlled notebooks and into the validated spreadsheets accurately and thoroughly.
  • Perform instrument operation, troubleshooting,  and instrument maintenance as required.  Prepare standards and reagents according to established procedures and specifications.
  • Follow cGMP and CAPS’ SOP requirements in all appropriate functions and notify supervisor of any observed issues and problems with the laboratory or testing results.
  • Conduct inventory and proper disposal of expired reagents, standards, chemicals used in the laboratory.
  • Receive and log in CAPS samples and prepare testing reports.
  • Perform proper hazardous waste removal.
  • May initiate out-of-specification (OOS) investigation and conduct follow through of the completion.
  • Support Special Projects and work with cross-functional group on development of special test methods. 
  • Adhere to all Safety, Laboratory, and CAPS’ policy.

 

 

Expertise: Knowledge & Skills

  • Work independently
  • Scientific instrumentation and computer skills
  • Interpret scientific data
  • Data compilation techniques
  • Professional demeanor
  • Technical writing skills
  • Project management skills
  • Troubleshooting and minor repairs of analytical instrument such as HPLC, GC, etc.
Target Based Range
65,130 - 81,410
Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • Bachelor’s degree in Chemistry (Master’s is a plus).
  • Minimum 2 - 3 years chemistry laboratory experience.
  • Theoretical knowledge of subject matter, CGMP, FDA guidelines, GLP and USP.
  • Knowledge in HPLC, GC/MS, ICP/MS, HLPC/MS.
  • Knowledge in EXCEL and PowerPoint is a plus.
  • Domestic Travel

 

Desired:

  • N/A.

 

 

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 www.bbraunusa.com.

 

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

Notices

Equal Opportunity Employer Veterans/Disabled