Job Number: 20021457

Location: Indianapolis Metro Area, IN

Date Posted: 9-7-2017

Job Title: Senior Specialist, Quality Control

Apply Now Apply Now

Cardinal Health is partnering with a Global leader in Specialty Medicine, to launch a new drug into the US market. In building this organization, we’re looking for exceptional talent.

What Quality Control contributes to Cardinal Health
Quality control is responsible for the analysis or inspection of products or processes for compliance with specifications and standards.

What is expected of you and others at this level:

  • Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes actions to resolve
  • Applies judgment within defined parameters
  • Receives general guidance; may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy

Accountabilities in this role:

  • Performs the analysis of raw materials, drug substance, in-process and drug product samples.
  • Trains other laboratory analysts in the use of laboratory equipment and execution of analytical methods.
  • Executes protocols designed for the qualification of analytical instrumentation.
  • Authors and executes protocols for method transfers.
  • Writes summary reports for method transfer protocols.
  • Performs the verification of compendia analytical methods.
  • Leads and facilitates the development and validation of new analytical methods as needed in alignment with ICH requirements.
  • Leads and facilitates the verification of compendia analytical methods.
  • Assists QC Supervisor, Chemistry in the establishment of Laboratory Information Management System (LIMS).
  • Performs drug product stability studies as needed.
  • Ensures results are consistent with acceptable test parameters and reports abnormal findings from Analytical tests to the QC Supervisor of Chemistry.
  • Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.

Qualifications:

  • B.S. degree in Chemistry, or related science field preferred.
  • Ability to see, hear, write (English), and speak (English) clearly in order to communicate in manufacturing setting - required.
  • 0 - 2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
  • Experience with equipment qualification, software validation, test method validation, and/or process validation.
  • Experience with Gas Chromatograph (GC), High Pressure Liquid Chromatography (HPLC) and UV/Vis Spectrophotometer.
  • Understand of equipment qualification and method validation and Technology Transfer process is a plus.
  • Experience with writing procedures/ reports and execution of laboratory test is desirable.
  • Must work well with others and understand how to be successful in a Team environment.
  • Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
  • Travel: 0%-5% overnight travel
  • Lift 50 lbs.
  • Ability to see fine particulate and differentiate colors in liquid solutions.

The primary work environment consists of a manufacturing facility for the production of radiopharmaceuticals, which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


To apply, your internet browser must be Internet Explorer Version 9 or above, FireFox, Safari or Chrome. If your current browser is Internet Explorer 8 or below, please upgrade your browser before applying

Learn how to update your browser