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)
- Performs routine equipment, facility, and utility qualification/validation.
- Develops cGMP compliant qualification/validation protocols.
- Executes Installation Qualifications, Operational Qualifications and Performance Qualifications.
- Performs requalification of equipment, facilities, and utilities to ensure compliance.
- Develops qualification and validation processes and procedures.
- Responsible for corporate wide tracking and execution management of all facilities, utilities, and equipment preventative maintenance, validations, and re-validations.
- Other duties as assigned or required.
- Experience and extensive knowledge of cGMP, FDA, ISO Standards
- Experience writing and executing compliant qualification and validation of equipment, facilities, and utilities
- Specialist on complex technical and business matters
- Understanding of medical terminology and laboratory calculations
- Ability to multitask and organize time efficiently
- Must be capable of working with small, delicate pieces of expensive equipment
- Must be capable of wearing all protective wear required for entry into the cleanrooms. This includes, but not limited to; sterile mask, gloves, overalls, hairnet, face mask/hood, shoe covers etc.
- Understands use and capable of working with pipettes, syringes, microscopes, graduates and other laboratory equipment
- Good communication and writing skills
- Good math skills
- Work is highly independent, however, as required, must work effectively with others as part of a team
- Must be capable of assuming a team lead role for the work group/team.
- Aseptic hand hygiene and garbing
- Requires 5+ years of related experience
- Bachelor’s degree in Chemistry or Microbiology
- Experience in a 503B Outsourcing facility
- Experienced/knowledgeable of applicable cGMP, ISO, FDA standards
- Clean Room experience
- Travel required up to 50% to other sites based on validation/PM schedule and at the discretion of management for corporate project needs.
- Must be able to stand for long periods of time
- Must be able to sit in front of computer for long periods of time
- Must be able to wear required safety equipment for long periods of time
- Fine motor skills must be sufficient to manipulate pipettes and small syringes
- Corrected vision close to 20/20 and acceptable for driving
- Majority of time is spent in the laboratory wearing protective laboratory attire (Examples of attire include: goggles, gloves, lab coat, shoe covers, hair net, and face cover)
- Minimal exposure to physical risks, such as operating dangerous equipment or working with chemicals
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.