Job description
Assist with oversight and support of all aspects of Quality and Compliance (Q&C) implementation and enforcement: including review and processing of quality documentation, Environmental Health and Safety activities, and maintenance of the Q&C systems. Assists in all aspects of the internal and external audit process.
What’s in it for you?
- Competitive compensation
- Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, employee discounts/promotions
- Competitive environment with company wide recognition, contests and coveted awards
- Exceptional company culture
- Recognized as a Top Workplace USA 2021
What will you be doing?
- Ensure maintenance of company and program specific Standard Operating Procedures (SOPs) and Policies, including authoring and/or Q&C editing of SOPs and Policies, oversight of SOP and Policy review schedules, working with subject matter expert SOP and Policy authors, and publication of SOPs and Policies
- Point person for the review and direction of requests sent to the Q&C mailbox, ensuring timely turnaround and completion.
- Assist in any/all internal, client and regulatory audits by supporting the audit lead.
- Participate in and lead Environmental Health & Safety initiatives at Ashfield including, but not limited to: participation in the EHS Committee, assist with the completion of EHS audits, and EHS reporting requirements to leadership.
- Assist in preparing quality and compliance reports for Senior Leadership and perform Q&C analysis.
- Assist with management and implementation of the Compliance Program and ensuring that the elements of an effective compliance program are met.
- Assist Client Account Management Team in the creation and revision of Client-Specific Standard Operating Procedures (SOPs) and participate in project start-up meetings as requested by the Director, Quality and Compliance
- Assist with the creation and tracking of Quality Agreements.
- Oversee the review and filing of deviations and tracking of open deviations to ensure timely completion. Assist with drafting of deviations as needed.
- Assist with the archiving, retention, and destruction process for the company. Track and manage the retention periods and the return or destruction of all project-specific hard copy and electronic materials.
- Safeguard patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA).
What do you need for this position?
- Bachelor’s Degree or related work experience required
- At least 1-2 years of experience as a Coordinator, Quality Assurance preferred
- Ability to challenge the status quo and propose process improvements
- Highly motivated
- Critical thinking and problem solving skills
- Strong organizational skills, detail oriented with ability to multi task in a very fast paced environment
- Exceptional written and verbal communication skills
- High computer proficiency with the Microsoft Office package, consisting of Outlook, Word, Excel, and PowerPoint. Microsoft Visio and/or Adobe Acrobat experience a plus.
About Ashfield Engage
Ashfield Engage, part of Inizio, is a global leader in commercialization services for the healthcare industry. We partner with our clients across Advisory, Healthcare Communications, Commercial, Patient Solutions and Medical Affairs to build creative, scalable and tailored health solutions that are executed flawlessly, to deliver positive outcomes for patients.
Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need.
To learn more about Ashfield Engage, visit us at:
https://ashfieldengage.com/
Ashfield Engage is proud to be an equal opportunity employer. Individuals seeking employment at Ashfield are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Ashfield will consider for employment qualified applicants with arrest and conviction records.
Ashfield Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be considered.
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