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 Assurance Manager will manage the Internal Quality Audit Program and work collaboratively with the Quality Assurance Manager (1st Shift) to evaluate conformance to company and regulatory requirements. The QA Manager shall perform quality system audits company-wide, assist with internal investigations of Quality Related Events, manage the company’s policy and procedure system, and have a thorough knowledge of company Quality Systems, policies and procedures, and experience trending data for metric and performance measurements for continuous quality and process improvement, and regulatory compliance.
- Manage and schedule internal quality audits company-wide. Travel is required (25-50%)
- Evaluate conformance to company and regulatory requirements. Assess the quality of files or records at each stage of process, identify gaps within the processes, interpret procedures and clearly communicate to personnel
- Initiate audit reports and distribute. Must support the audited site with development of corrective and preventative actions to address any significant non-compliance identified in the audits
- Work collaboratively with company General Counsel and Regulatory Affairs personnel to ensure current understanding and clarification of existing or new rules and regulations from applicable regulatory bodies and committees (example: Code of Federal Regulations Parts 210 and 211, cGMP, FDA Guidance, and USP guidelines). Disseminate this information as needed
- Working under the direction of the Director of Quality, assist in the investigation of internal or external quality related events. Verify corrective and preventative actions are in place and working as part of the internal audit process
- Implement metric trend system for internal audit information or other key quality metrics needed.
- Work collaboratively with Quality Control and Operations / Production to ensure they understand quality systems and regulatory requirements and expectations. May assist in resolving escalated issues and task ownership to the corresponding parties
- The QA Manager manages the administration of the Quality Compliance Training program for internal staff, this may include; presenting quality and trend information to senior managers, training of staff at audit site, quality presentations for new staff or departments related to a quality event, and developing training material
- Assist Director of Quality in conducting biannual quality assurance meetings or Quality related training for existing or new programs impacting Pharmacy staff or other internal staff
- Work collaboratively with the Director of Quality to develop new Quality policies or procedures, and roll out
- Conduct training for all Quality Assurance Specialists and Quality Assurance Technicians
- Perform other duties assigned by the Director of Quality to ensure uniform quality assurance / control for continuous quality improvement throughout the company
- Work collaboratively with Document Control to perform change control process and for Avella policies and procedures system
- A BS degree or equivalent years of work experience shall be considered
- Minimum of 5 years Quality Assurance / Quality Control experience in pharmaceutical industry
- Knowledge of laws and regulations regarding the use of pharmaceuticals for human and animals (FDA and State)
- Experience working with regulatory agencies
- Strong knowledge of HIPPA rules and regulations
- Experience working in a fast paced environment, where timelines and follow-thru are key, and ability to multi-task critical
- Professional appearance, with excellent verbal and written communication skills including presentation skills
- Excellent computer knowledge / competence in Microsoft Office with strong Excel and Word experience
- High initiative with demonstrated results achievement, orientation, and a team player
- Self-motivated, dependable, organized, and must complete task start to finish with minimum supervision
- Lean Six Sigma,
- Knowledge of 503B
- FDA, cGMP, and USP experience desirable
Knowledge of Quality Assurance programs or systems
Pharmacy Technician certification or experience with sterile and non-sterile compounding experience
Experience working directly with a licensed Pharmacist specializing in quality assurance
Physical Demands and Work Environment:
The physical demands and work environment are characteristic of those found in a typical laboratory environment. Capable of wearing all protective lab attire required for long periods of time. Some travel is required. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.
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: 503B; Quality Assurance, Quality Control, Quality, Pharmaceutical, HIPPA, Manager