Quality Assurance and Compliance Officer
- Posted: over a month ago
Provides leadership, direction, technical expertise as well as compliance to the Pharmacy Quality Assurance Program in accordance with USP, State and Federal regulatory agencies. Actively provides guidance regarding compliance to Pharmacy Policies, Procedure and Regulations. Should possess pharmacy quality and regulatory experience in order to provide general compliance guidance to the Pharmacy Leadership Team regarding adherence to federal and state regulatory requirements for a sterile and non-sterile compounding pharmacy. Personnel compliance and compounding training and formulation development is also an essential responsibility.
Benefits & Perks
- Medical, Dental, Vision and more
- 401k + Employer Contribution
- Generous PTO
- Fun/productive atmosphere and awesome co-workers
What you’ll be doing
FIVE CORE ROLES
- Quality Assurance and Compliance
- Performance and Process Improvement Initiatives
- Formulation Development
- Medical/Clinical Liaison
- Employee training and development
QUALITY ASSURANCE & COMPLIANCE
- Lead, develop, implement and maintain quality strategies, procedures and systems in alignment with USP, state, and federal guidelines and company objectives as well as those pertaining to ACHC and NABP.
- Apply knowledge of the most current regulations to ensure pharmacy quality compliance.
- Provides necessary implementation and deployment of SOPs in accordance with USP 795/797/800
- Manages the evaluation of quality events, incidents, and complaints
- Ensures proper documentation, investigation, and action plans of all QEI’s
- Liaise with suppliers and third party vendors to ensure appropriate qualification of quality and sterility
- Participates in the creation and amendments to Policy and Procedure documents to comply with the requirements
- Keep apprised of notices and FDA and state board compliance policies subject to 503A Compounding Pharmacies
- Perform audits on operations and quality system to determine the level of compliance to existing and newly instituted regulatory procedures and or corrective action plans
- Communicate with individual departments to notify and address non-compliance issues
- Assist in communication, coordination and management of external and mock audit
- Prepare documentation for submission to state and federal agencies
- Investigate potential issues of regulatory and or privacy (HIPAA) non-compliance and assist with root cause analysis, corrective action and impact reports for internal departments
- Document and maintain project plans and status reports as related to compliance programs, mock inspections, audits, and other ad hoc initiatives as needed
- Represents company during external inspections of pharmacy. Prepares staff for readiness of any regulatory agency inspections and accrediting bodies.
- Implements ongoing quality improvement processes working with interdepartmental teams
- Ensure follow through on all decisions made during weekly meetings
- Encourage employee engagement and productivity during meetings and support consistency in meetings and collaboration
- Anticipate process control problems and takes corrective action to prevent or resolve.
- Oversee the formulation development process and create new formulas in accordance with company policies and procedures, and USP, state, and federal guidelines.
- Liaise with Customer Care Team to respond to formulation development requests submitted by Providers
- Ensure that new formulations are in line with company objectives and within budget, comply with USP guidelines, and are delivered to the recipient expeditiously.
- Review, audit, and improve existing formulas in accordance with company policies and procedures.
EDUCATION & TRAINING
- Develops and trains staff on all regulatory requirements and ensures strict adherence to company SOPs
- Trains and educates new employees during orientation on USP guidelines and company policies and procedures
- Ensures all staff training and competency on HIPAA and Fraud, Waste, and Abuse is current
ACTIVATING CORE VALUES
- Play a critical role in creating and implementing Company Culture and Core Values
- All leaders are required to be culture ambassadors and to lead by example
- Contribute to and foster a healthy work environment
- Encourage team work within and between departments.
- Encourage and engage in constant communication
- Swiftly discourage behavior that is not in full alignment with Company Culture
- Leads development of department goals, systems, and objectives
- Attend and contribute to weekly leadership meetings.
- Develop management skills by completing leadership development programs and engaging in different ways to continually develop professionally (books, online courses, etc)
- Collaborate with management team to identify leadership training opportunities.
- Set new goals and plans for all leadership to pursue
What you’ll bring to Akina
- Values of Excellence in all things, Service-oriented character, Compassion, and a Go-Getter approach
- Minimum 5 years experience of Pharmacy Regulatory and Quality oversight
- Formulation Development experience in the pharmacy industry
- Extremely detail oriented with respect to documentation and communication
- Excellent problem solving skills that inspire team confidence and respect while creatively motivating team members
- Technical review and writing skills including Protocols, Test Methods, Standard Operating Procedures and ability to respond to Regulatory Agency Observations
- A positive attitude and a strong work ethic that is contagious
- Flexibility and a strong desire to do what is best for your team
Licenses and Certifications
- BS/BA degree in the pharmacy, nursing, or physical sciences or related discipline
- Knowledge and experience in a compounding/specialty pharmacy is preferred but not necessary
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