Technician II, Quality Control

What Quality Control contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.

Job Summary
The Technician II, Quality Control performs varied product inspections or analysis generally of finished goods components, incoming materials or new products, by observing, measuring and recording data using applicable measurement tools. Compiles and inputs data, documents and process findings and interprets results. Completes applicable documents needed for the release of product to the field. This job follows demonstrates knowledge of testing methods, product usage, and applicable procedures according to regulations, and standards and adheres to established policies and procedures but also participates in the establishment of future inspection procedures.

Schedule/ Location:

• Onsite in Aurora, CO.
• 40 hours. Saturday through Tuesday; 10-hour shifts. Approximate hours between 10:00 am and 8:00 pm.  
• Holidays as needed. Overtime as needed with little to no notice. Candidate must be flexible to work different days, schedules and/or hours based on business needs.

Responsibilities

• Operates analytical equipment, performs analytical tests, interprets results, and documents findings in accordance with SOPs and regulatory requirements.
• Responsible for analysis of raw materials, drug substance, in-process, and drug product testing.
• Responsible for test/procedures to be performed as well as documentation and reporting requirements.
• Interact 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.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Follows/mentors GDP/cGMP requirements.
• Actively partner 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 cGMP.
• Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Able to challenge, appropriately, the design, conduct, and reporting of cGMP 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 evaluates their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the cGMP Quality Management System.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Performs other job duties as assigned.

Qualifications

• High School diploma, GED or equivalent, or equivalent work experience, preferred
• 1-3 years of experience, preferred
• 0 - 3 years of relevant experience with wet chemistry, TLC, analytical instrument maintenance, troubleshooting and qualification preferred
• 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. 
• Strong communication skills.
• Ability to lift up to 40 lbs.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus

Performance Expectations

• Demonstrates a commitment to the organization’s 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/or conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives

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.

• 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; talk or hear; and taste or smell. The employee must occasionally lift or move up to 40 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 a professional office environment within a radiopharmaceutical manufacturing facility as well as the laboratory setting. 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 groups. 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.

What is expected of you and others at this level

• Applies acquired knowledge and skills to complete standard tasks
• Readily learns and applies new information and methods to work in assigned area
• Maintains appropriate licenses, training and certifications
• Works on routine assignments that require some problem resolution
• Works within clearly defined standard operating procedures and/or scientific methods
• Adheres to all quality guidelines
• Works under moderate degree of supervision
• Work typically involves regular review of output by work lead or supervisor
• Refers complex unusual problems to supervisor

Anticipated hourly range: $20.20 per hour - $28.80 per hour

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 04/26/2025 *if interested in opportunity, please submit application as soon as possible.

The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Salary : $20 - $29