UnitedHealth Group QC Technician 1 (Sample Coordinator) - Phoenix, AZ in Phoenix, Arizona
Welcome to one of the toughest and most fulfilling ways to help people, including yourself. We offer the latest tools, most intensive training program in the industry and nearly limitless opportunities for advancement. Join us and start doing your life's best work .
The Quality Control Technician – Cleanroom Sample Coordinator will manage the cleanroom sampling program and work collaboratively with the Quality Control Manager to ensure conformance to company and regulatory requirements. The Quality Control Technician – Cleanroom Sample Coordinator shall coordinate all environmental monitoring, personnel monitoring, intermediate samples, and finished product samples and have a thorough knowledge of company Quality Systems, policies and procedures, and experience tracking and trending data for metric and performance measurements for continuous quality and process improvement, and regulatory compliance.
Oversees and independently performs a variety of complex sample and standard tasks (receipt, check - in, login, labeling, launching, inventory, transport, check - out, return, disposals, etc.) in support of the aseptic manufacturing.
Communicates status of samples with Quality, Operations, and Laboratories.
Point person for coordinating activities with contract and internal testing laboratories.
Reviews and provides feedback on laboratory requests, ensuring compliance with applicable SOPs.
Completes investigation and deviation forms as necessary, and determines appropriate corrective and preventative action.
Collects and distributes all samples for required testing and to ensure compliance with established procedures.
Submits required samples to contract and internal laboratories.
Maintains inventory of all retain / reserve samples.
Reconciles all samples that have completed testing.
Completes all required documentation for sampling program (sample submission, inventory, reserve sample visual inspections, etc.)
Supports Internal and External Audits
Maintains chain of custody of all samples.
Monitors storage of all samples throughout the process.
Assists in preparation and implementation of SOPs and Quality Systems
High school education or GED (or higher)
1+ years Quality Assurance / Quality Control experience in pharmaceutical industry.
Proficient in Microsoft Word (ability to send documents) Microsoft Excel (ability to create spreadsheets)
Ability to work Mondays - Fridays 6:30 AM - 3:00 PM
BS degree in Sciences
6+ months experience with trending data
Aseptic Processing, Lean, Six Sigma, 503B, FDA cGMP, and USP experience desirable
When it comes to providing new hope and a new path to wellness, specialty pharmacy companies like Avella fill a unique and important role. Avella , now part of the Optum and UnitedHealth Group family of businesses, is bringing breakthrough medications, innovative clinical pharmacy programs and technological tools to providers and their patients across the nation. We create a viable level of access to many of the newest, most advanced medications in addition to a suite of tools that include mobile apps, text messaging tools and smart pill bottles. Whether you bring a clinical or business background to our opportunities, you can be sure that you'll be making a meaningful contribution to important solutions and services. Find out more about how you can start doing your life's best work.SM
Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity / Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.
Keywords: Quality Control, Technician, Material Handler, Material Sampler, IHG