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 initiati