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About UHG

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

Quality Control Manager - Avella - Houston, TX

UHG - Houston, Texas

Posted: 12/17/2018

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)

 

The Quality Control (QC) Manager will oversee, manage and ensure all day-to-day QC operations. Such daily oversight shall include, but not be limited to, management and scheduling of testing, sampling, routine team member tasks, environmental monitoring, equipment validation, etc. for both of the in-house laboratories (microbiology) and contract laboratories. Will write policies & procedures. Will perform training for new employees both in person & via web training system.  

 

Primary Responsibilities:

  • Implement cGMP system(s) and ensure compliance with all procedures and policies
  • Write and revise applicable policies and procedures for departments as aligned with corporate policies and expectations
  • Oversees the daily operations of the microbiology department
  • Oversees QC equipment validation, maintenance and calibration and QC laboratory scheduling and maintenance
  • Manages the EM program and corresponding personnel
  • Manages the microbiology laboratory activities and personnel. Main team tasks include environmental testing, personnel testing, aseptic process simulation testing, endotoxin testing, and incubation
  • Manage the review and approval of specifications and test methods
  • Reviews and approves product testing for finished drug product and raw ingredients
  • Evaluates and approves out-of-specification (OOS) investigations; trends the OOS’s. Provided tracking and trending data to Quality Assurance on a monthly basis
  • Ensure the completion of all non-conformance, deviations and other quality related issues associated with laboratory investigations
  • Ensure the laboratories are properly equipped to maintain a high performance level for reliable test results applicable with all GMP’s and GLP’s
  • Ensure laboratory personnel meeting required training and / or certification(s)

Required Qualifications:

  • A BS degree in a related science field or equivalent years of work experience shall be considered

  • Knowledge of Quality Control and Assurance programs or systems

  • Experience managing a microbiology and / or chemistry lab

  • Minimum of 4 years quality control experience in pharmaceutical or medical device industry

  • Minimum of 2 years management experience

  • Knowledge of laws and regulations regarding the use of pharmaceuticals for human and/or animal use (FDA and State)

  • Experience working with regulatory agencies

  • Experience working in a cGMP environment

  • Experience working in clean rooms, sterile rooms & aseptic technique

  • Must have excellent verbal and written communication skills including presentation skills

  • Excellent computer knowledge in Microsoft Office with strong Outlook, Excel and Word experience

  • High initiative with demonstrated results achievement, orientation, and a team player

  • Must be self-motivating, dependable, organized, and must complete task start to finish with minimum supervision

  • Experience working directly with licensed Pharmacists specializing in GMP operations, QA and QC  

     

Preferred Qualifications:

  • Experience working with a 503B Compounding Pharmacy
  • Experience with Lean, Six Sigma, FDA, BOP, and USP
  • Experience working in a fast paced environment, where timelines and follow-thru are key, and ability to multi-task critical

 

 

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: Houston, Texas, TX, regulatory, cGMP, FDA Guidance, USP, Quality Assurance, Quality Control, pharmaceutical, manager, audit, compliance, Lean Six Sigma, 503B, sterile, non-sterile compounding, Specialty pharmacy

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