Quality Control Senior Specialist

Indianapolis - contract pharmaceutical manufacturing

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.

  • Demonstrates detailed oriented attention in all facets of responsibilities.
  • Performs analytical evaluation or test of products or processes.
  •  Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
  • Adheres to established policies and procedures.
  • Establishes test methodology.
  • Provides technical guidance and training to others on SOPs and quality guidelines.

Accountabilities in this role:

  • Performs the analysis of raw materials, drug substance, in-process and drug product samples.
  • 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.
  • May lead and facilitate the development and validation of new analytical methods as needed in alignment with ICH requirements.
  • Verification of compendia analytical methods.
  • Performs drug product stability studies.
  • 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
  • 2 or more years of relevant work experience.
  • 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. 
  • HACCP knowledge preferred.
  • Experience with Gas Chromatograph (GC), High Pressure Liquid Chromatography (HPLC) and UV/Vis Spectrophotometer preferred.
  • Understand the Validation and Technology Transfer process and have experience with writing procedures/ reports and execution of laboratory test.
  • Must work well with others and understand how to be successful in a Team environment.
  • Detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
  • 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.