Cardinal Health Chemist, Quality Control in Indianapolis, Indiana

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

  • Operates analytical equipment, performs analytical tests, interprets results and documents findings in accordance with SOPs and regulatory requirements.
  • Authors and executes analytical method transfer process and product stability studies. Verifies compendia analytical methods.
  • Executes analysis of raw materials, drug substance, in-process and drug product testing.
  • Executes protocols designed for the qualification of analytical instrumentation.
  • Develops and validates new analytical methods as needed in alignment with ICH requirements.
  • Handles tests/procedures to be performed as well as documentation and reporting requirements
  • Interacts regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products.
  • Ensures results are consistent with acceptable test parameters and reports abnormal findings from Analytical tests to the QC supervision.
  • Acts as champion for Quality, GMP compliance and EHS/Radiation Safety practices.
  • Follows/ mentors GDP/GMP requirements.
  • Actively partners with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
  • Assists in the release of the final product in compliance with GMP.
  • Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
  • Ability to network across business and functional units to achieve positive outcomes.
  • Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.
  • Understands technical/release product issues and evaluate their potential impact on product quality and compliance.
  • Provides ideas for continuous improvement of the GMP Quality Management System.
  • Escalates complex issues to management in a timely manner.
  • Prioritizes and ensures work is delivered in an efficient way.
  • Models the characteristics outlined in the Cardinal Health Leadership Essentials- Professional and Business Support.
  • Demonstrates a commitment to the organizations mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
  • Works as part of a team with others and shows respect and values diversity toward others.
  • Demonstrates efforts to discovering, meeting and advocating for the customer’s needs.
  • Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
  • Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
  • Acts calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.
  • Performs other job duties as assigned.

Qualifications

  • B.S. degree in related field (Chemistry, Biochemistry, Biology) or related science field strongly preferred
  • 2+ years experience in related field preferred
  • Visual acquity (ability to see fine particulate) and differentiate colors in liquid solutions.
  • 2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
  • 3 years of relevant experience with gas chromatography (GC), high pressure liquid chromatography (HPLC), UV/Vis Spectrometer, Analytical instrument maintenance, troubleshooting and qualification preferred
  • Must have experience with equipment qualification, test method validation, and/or process validation preferred
  • Must 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
  • Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
  • Have experience in batch record writing experience, SOPs, and deviation investigations.
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
  • Strong communication skills
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl. The employee must occasionally lift or move up to 50 pounds.
  • Travel: 0%-5% overnight travel

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

The primary work environment consists of a radiopharmaceutical manufacturing facility. Employees may handle radioactive materials and may be 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.

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.