QA Specialist 1 (Incoming Materials)

UnitedHealth Group
Type

Junior industry position

Position Description
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.


Positions in this function perform various duties in support of the production control and testing of compound manufactured drugs:

Primary Responsibilities:
Final product testing
Product testing review and support
Environmental and personnel monitoring
Qualification and validation
Equipment and clean - room sterilization
Raw material and component review and testing 
Batch review and disposition
Internal and external audits
Document control management
Quality system management
Moderate work experience within own function.
Some work is completed without established procedures.
Basic tasks are completed without review by others.
Supervision / guidance is required for higher level tasks.
Responsible to ensure that each shipment of materials are sampled and tested to ensure that it meets appropriate specifications.
Responsible for sending out routine QA test samples to contracted Laboratory for testing / analysis, receive, and review of test results for acceptability
Responsible to disposition (approve or reject) all incoming materials, and the authority to review supplier / vendor records to assure that no error has occurred or, if errors occurred, that they have been fully investigated.
Work under the direction of the QA Manager to investigate all discrepancy and failure investigations and the development of oversight of appropriate corrective actions and preventative actions regarding rejected lots of incoming materials (including out - of - specifications results), and unexpected results or trends.
Responsible for reading and understanding analytical and microbiological lab test results and attaching them to the corresponding incoming materials record(s) in a timely manner
Responsible for keeping complete records of all tests performed to ensure compliance with established specification and standards, including examinations and assays.
Responsible for reviewing and storing CoA for all incoming materials utilized in GMP operations.
Work collaboratively with company Regulatory Affairs personnel to ensure current understanding of all rules and regulations from applicable regulatory boards and committees (example: State Board of Pharmacy, FDA, USP guidelines and OSHA)
Work collaboratively with the Operation supervisors and technicians to ensure our quality and compounding policies and procedures are kept current.
Assist the QA Manager in conducting Quality Assurance audits
Assist QA Manager in conducting Quality Assurance meetings or Quality related training for existing or new programs impacting all personnel.
Work collaboratively with the Quality Assurance Manager in: Drafting of new QA Departmental procedures, review of new or revised company procedures, and training and development of all newly hired Quality Assurance Specialists
Perform other duties assigned by the QA Manager to ensure uniform quality assurance throughout the entire company.
Required Qualifications:

High school education / GED (or higher)
A minimum of 1 - year Quality Assurance / Quality Control experience, preferably in pharmaceutical industry.
Proficient in MS products - the ability to send documents in Word and the ability to created documents in Excel

Has to have the ability to work an 8 hr shift between the hours of 6a - 6p Mon - Fr

OptumRx is an empowering place for people with the flexibility to help create change. Innovation is part of the job description. And passion for improving the lives of our customers is a motivating factor in everything we do.

 

If you're ready to talk about groundbreaking interactions, let's talk about what happens when a firm that touches millions of lives decides to gather results from millions of prescriptions every month and analyze their impact. Let's talk about smart, motivated teams. Let's talk about more effective and affordable healthcare solutions. This is caring. This is great chemistry. This is the way to make a difference. We're doing all this, and more, through a greater dedication to our shared values of integrity, compassion, relationships, innovation and performance.  Join us and 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.

More Information

Type

Junior industry position

Phoenix%2C%20United%20States

Phoenix , United States