Cardinal Health
Chemical/Pharmaceutical Operations Technician I
At a glance
Location: US-CO-Aurora Map
Posted: 11/12/2019
Closing: 12/11/2019
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Cardinal Health
Job description

Cardinal Health Nuclear Manufacturing Services is a specialized manufacturing facility that involves the production of radiopharmaceuticals-nuclear drugs-for use in nuclear medicine diagnostic studies.


What Chemical/ Pharmaceutical Operations contribute to Cardinal Health

  • Reports to Supervisor, Chemical/Pharmaceutical Operations  
  • Perform duties per standard operating procedures for the preparation of the drug product manufacturing areas and equipment to include; cleaning, labeling, staging, and equipment calibrations
  • Prepare drug product capsules for manufacturing to ensure production demand is met
  • Dispense capsules and perform in-process quality assays to ensure finished product falls within specifications
  • Perform capsule finishing processes per standard operating procedures which include the manual placement of capsules into containers according to drug product label for quantity and strength
  • Assemble packaging for drug product shipments and perform packing steps of finished product containers against the customer packing list
  • Prepare and review all shipping paperwork to ensure it is complete, accurate and compliant with State and Federal Regulations and standard operating procedures
  • Complete batch record by verifying that all sections pertinent to the manufacturing process are accurate and complete
  • Clean and maintain manufacturing work areas and ancillary rooms in a clean and orderly state
  • Operate company vehicle to receive in-bound packages at the airport and transportation of out-going packages according to State, Federal and standard operating procedures
  • Perform and adhere to all radiation safety procedures and policies related to the drug product manufacturing process to include but not limited to the following; radioactive waste disposal, radiation contamination surveys and wipe tests, area surveys, package surveys, personnel monitoring, thyroid bioassays, and environmental monitoring
  • Attend meetings and training as required
  • Perform other related duties as required to ensure the goals and objective of the department are met

What is expected of you and others at this level  

  • Demonstrates attention to detail, strong initiative and is able to work with changing priorities
  • Can set up tests, operate equipment, record data, and use unsupervised discretion in the evaluation of data, often working without supervision
  • Can follow a manufacturing batch record and ensure good documentation practices during all entries in batch records, logbooks, and forms
  • Can follow all Environmental Health Safety procedures to ensure one’s personal safety and the safety of fellow workers involved with the production of radiopharmaceuticals
  • Must follow all radiation safety procedures to maintain safe, acceptable levels as indicated by government guidelines, including proper survey procedures, personal monitoring, and waste handling
  • Understands cGMP, FDA, NRC and OSHA regulations
  • Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the manufacturing site philosophy and vision
  • The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service

Accountabilities in this role

  • Performs standard operating procedures to meet current good manufacturing practices (cGMP)
  • Performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products
  • This may include bulk drug substance manufacturing, parenteral filling, use of isolator equipment, manual and automatic inspection, labeling, packaging, component receipt and verification, and scheduled area sanitization
  • Handles raw materials and intermediate or finished products
  • Mixes chemical compound ingredients and fills parenteral vials for further processing so formulation/filling experience is desired
  • Performs general maintenance as required on various pharmaceutical manufacturing equipment
  • Performs other job duties as assigned

Performance Expectations

  • Models the characteristics outlined in the Cardinal Health Leadership Essentials- Operations and Manufacturing
  • 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
  • The ability to act calmly and patiently when working under pressure and/conditions of stress
  • Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives

Qualifications:

  • High school diploma or equivalent
  • Preferable to have 0-2 years of experience in pharmaceutical or medical device industry FDA regulated industry
  • Possess an understanding of cGMP/compliance requirements for pharmaceutical products

Physical/Mental Requirements

  • 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
  • Ability to hear, write, and speak clearly in order to effectively communicate with other staff members
  • Manual dexterity required for occasional reaching, lifting and holding of small objects
  • Demonstrated manual dexterity and hand-eye coordination in order to label, dispense, finish, and package drug product
  • The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; stoop, kneel, crouch or crawl; and talk or hear
  • The employee must occasionally lift or move up to 75 pounds
  • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus
     

Work Environment

  • The primary work environment consists of the manufacturing area of the facility 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.

Chemical/Pharmaceutical Operations Technician I