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Careers at UnitedHealth Group

 

We have modest goals: Improve the lives of others. Change the landscape of health care forever. Leave the world a better place than we found it. Such aspirations tend to attract a certain type of person. Crazy talented. Compassionate. Driven. To these individuals, we offer the global reach, resources and can-do culture of a Fortune 5 company. We provide an environment where you’re empowered to be your best. We encourage you to take risks and in return, offer a world of rewards and benefits for performance. Exceeding your limits is an exceptional start to your life's best work.SM

 

Just like you, we are driven by a set of fundamental principles that are guiding our way forward. Our values of integrity, compassion, relationships, innovation, and performance serve as a foundation to transform health care. Are you in? Learn more about your future at UnitedHealth Group at careers.unitedhealthgroup.com

 

Job Category:

Pharmaceutical

Country:

US

Approximate Salary:

Not Specified

Position Type:

Full Time

Pharmaceutical QA Specialist (Batch Release) - Avella Specialty Pharmacy - N.W. Phoenix

UHG - Phoenix, Arizona

Posted: 11/17/2018

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)

 

Work collaboratively with the Quality Assurance Manager to perform quality assurance audits, investigate internal or external quality related complaints, perform finished product batch release and perform other assigned duties to ensure uniform quality assurance throughout the entire company. 

 

Primary Responsibilities:

  • Responsible to ensure that each batch of finished drug product is 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 finished drug product, and the authority to review production 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 finished drug product (including out-of-specifications results) unexpected results or trends, and stability failures

  • Responsible for reading and understanding analytical and microbiological lab test results and attaching them to the corresponding Batch Record 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 generating CoA for the finished product that will be sent to the customer as applicable

  • 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 Internal 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

 

Knowledge Skills and Abilities:

  • Knowledge of laws and regulations regarding cGMP Human Drug Compounding

  • possess a professional appearance, with excellent interpersonal communication skills including presentation skills, and multitask ability

  • Strong computer skills, knowledgeable with standard Microsoft Office suite, email, document scanning, and strong Excel and Word experience

  • Ability to stand for long periods of time while working in laboratory,

    work in a fast paced environment and work with small, delicate, complex instruments and highly expensive equipment in the laboratory

  • Be capable of wearing all protective lab attire required by law, for long periods of time while working in the laboratory

  • Adequate vision to read all laboratory equipment measurements accurately

  • Self-motivated and organized with minimum supervision

  • Full knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate to the Human Drug Compounding.


Required Qualifications:

  • A minimum of 2 years Quality Assurance / Quality Control experience

  • A minimum of High School diploma or equivalent

  • Full knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate to the Human Drug Compounding

     

Preferred Qualifications:

  • Strong preference given to candidates with Pharmaceutical QA / QC experience

 

Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do 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.

 

 

Job Keywords; FDA, cGMP, CFR Parts 210 and 211, USP, Chapters / Monographs, Pharmacy, Pharmaceutical, Drug, Compounding, Quality, QA, QC, Test Samples, Laboratory, Batch Release

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