What are the responsibilities and job description for the Accreditation & Audit Specialist position at BLG Biologics, Inc.?
Current Need :
The purpose of the Accreditation and Audit Specialist is to ensure organizational excellence and integrity by rigorously managing and upholding compliance with industry standards, regulatory requirements, and internal policies. This role is dedicated to safeguarding the organization's accreditation status through meticulous audit management, fostering compliance with client / manufacturer standards, fostering a culture of continuous improvement, and enhancing operational efficiency. By providing expert guidance, comprehensive training, and clear communication with accrediting bodies, the Accreditation and Audit Specialist plays a pivotal role in mitigating risks and ensuring sustainable compliance, thereby supporting the organization's mission and long-term success.
In addition, the Accreditation & Audit Specialist will proactively identify potential quality opportunities through auditing of operational procedures, key performance metrics, and transactions so that operational processes are being executed in accordance with defined processes, policies and procedures, regulations and service level standards.
Candidate must reside within a commutable distance to Cary, NC to be present for audits (on average up to 5 days per month onsite).
Key Responsibilities :
Ensuring the organization meets all necessary standards and regulations required for accreditation and is compliant with pharmaceutical manufacturer requirements as audited.
Planning, coordinating, and conducting internal and external audits to evaluate the effectiveness of the organization's processes and controls related to accreditations and pharmaceutical manufacturer requirements.
Identifying areas for improvement based on findings and working with relevant departments to implement necessary changes to enhance operational efficiency and compliance.
Maintaining accurate records of audits and accreditation processes and preparing detailed reports for management and accrediting bodies.
Educating staff about compliance requirements, audit processes, and the importance of adhering to standards to maintain accreditation and pharmaceutical manufacturer contracts.
Identifying potential risks related to accreditation compliance and / or pharmaceutical manufacturer audit requirements and developing strategies to mitigate them.
Acting as a point of contact between the organization and accrediting bodies / pharmaceutical manufacturer audit teams, ensuring clear communication and timely submission of required documentation.
Providing general Quality support as needed
Minimum Requirement :
Degree or equivalent and 4 years relevant experience including accreditation, audit, quality assurance, etc.
Critical Skills :
Healthcare and / or pharmacy experience highly preferred
Experience in building internal and external relationships / partnerships
2 years related to leading audits
2 years related to accreditation attainment
2 years related to project management
Strong quality orientation including the ability to focus on details and adherence to standards
Ability to communicate effectively, both written and oral
Additional Skills :
Specialty pharmacy experience is a plus
Oncology and rare disease experience is a plus
CareTend experience is a plus
MasterControl experience is a plus
Six Sigma and / or Lean experience is a plus
Proficiency in Microsoft Word, Excel, and PowerPoint applications
Working Conditions :
Hybrid Onsite / Home Office
Ability to travel up to 20% of the time
We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please
Our Base Pay Range for this position
74,900 - $124,800
Salary : $74,900 - $124,800
