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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 Document Controller - Chemistry Coordinator

UHG - Houston, Texas

Posted: 11/15/2018

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)

 

Position Summary:

 

The Quality Document Controller will be responsible for assisting with the managing, creation, issuance and retention of the Quality System documentation.  He/she will provide administrative support to the Director of QA to ensure that all control documents are current and accurate. Manages Waste and Pest Control programs. Facilitates communication with other departments and outside services. Performs other administrative duties as assigned.

 

Primary Responsibilities:

  • Assist in generating and revising cGMP documents to include but not limited to SOP’s, Independent forms and Batch Records

  • Review and routinely audit documentation (SOP binders, personnel binders, certificates, etc.) verifying that records are current

  • Review routine facility data to ensure quality standards are met and to verify compliance with applicable SOP and regulatory requirements (cGMP, FDA)

  • Coordinate applicable training with HR and training leadership

  • Manages the maintenance and preventative maintenance log ensuring that calibrations/inspections are current

  • Coordinates and maintains Smartsheet of approved consumable with QA Pharmacist and Director of QA or Designee

  • Schedules routine pest control treatments for approved vendor and reviews reports and trending information

  • In collaboration with Production and QA Pharmacist, Document Controller is responsible for the storage, management and evaluation of expiration date of retain samples

  • Responsible for managing storage and disposal of production waste and maintaining all records as proof

  • Provides routine feedback to Director of QA regarding assigned projects and other activities

  • Knowledgeable and efficient in MS Word, Excel, Adobe/Nitro and SharePoint

  • Provides support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits

Knowledge Skills and Abilities:

  • Basic knowledge of Document Control fundamentals, Quality Systems and GMP requirements
  • Understanding role of QA and QC in an organization
  • Ability to multitask and organize time efficiently
  • Excellent attention to detail
  • Works effectively with others as part of a team

Required Qualifications:

  • 3 years of experience in Document Control (Preferably with Pharmaceuticals)
  • Proficient knowledge of Internal Auditing and Change Control practices in accordance with GMP requirements
  • Ability to manage numerous projects and tasks in parallel to one another (project management).
  • Ability to review current processes and implement productivity and compliance improvements
  • Strong “people skills” to be able to deal with various personalities and levels within and outside of the organization
  • Excellent verbal and written communication skills; ability to write reports and SOPs
  • Excellent organizational skills and detail oriented Knowledge of Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

 

Preferred Qualifications:

  • Skilled at reporting metrics showing performance and trending; advanced data analysis skills
  • Experience auditing to 21CFR

 

 

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.

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