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 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.
This is a Non-Exempt Administrative support position. The hours will be Monday - Friday from 8am - 5pm.
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, Outlook and SharePoint.
Provides support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits
- Must have previous Admin/Support experience
- Basic knowledge of Document Control fundamentals, Quality Systems and GMP requirements
- Must be familiar with SOP’s and tracking documents
- Ability to multitask and organize time efficiently
- Excellent attention to detail
- Works effectively with others as part of a team
- Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus.
- 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
- Excellent verbal and written communication skills; ability to write reports and SOPs required.
- Excellent organizational skills and detail oriented Knowledge of Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Previous Document Control experience
- Proficient knowledge of Internal Auditing and Change Control practices in accordance with GMP requirements
- Understanding role of QA and QC in an organization
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, Administrative, SOP, track documents, cGMP, FDA Guidance, USP, pharmaceutical, audit, compliance, 503B, sterile, non-sterile compounding, Specialty pharmacy