Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Consulting Operations team as a Consultant, Project Associate (GCP Quality) today!

In this role, you will leverage your Quality Assurance expertise to provide support to Halloran clients and serve as a key internal partner to project leads.

Characteristic Duties:

• Support the development of documents that support a Quality Management System, including policies, Standard Operation Procedures (SOPs) and work instructions
• Assist in the development of training content for delivery across GxP disciplines (e.g. GCP, GMP, GVP)
• Support Inspection Readiness activities, including process mapping, storyboarding, interviews and behavioral training
• Provide support for a wide variety of audits, including audit report writing
• Provide gap assessment support including gap identification and documentation, as well as gap remediations as needed
• Support project planning and development, including developing timelines and desired milestones/deliverables, communication plans, resource and budget objectives and ensuring understanding of all partners; ensure progress of these goals
• Regularly collaborate with client and Halloran leaders to report on project progress and advise on solutions, assisting in developing agendas and taking minutes
• Communicate and develop solutions to address any risks or issues for project impact and long-term success of client and Halloran
• Support project lead in educating existing and potential clients on Halloran services and opportunities for partnerships, assisting with developing support strategy
• Assist in the authoring of proposals and statements of work
• Participate in internal activities such as publishing articles and other examples of thought leadership, serving as a subject matter representative on process optimization efforts
• Continue to build subject-matter expertise by attending conferences, workshops, and other relevant learning opportunities, speaking as a face of Halloran if opportunities arise
• Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
• Other duties and responsibilities as assigned

Qualifications:

Required:

• Bachelor’s Degree and a minimum of four years of related experience in a Life Science setting focusing on Drug, Medical Device, Biologic or other therapeutic development
• Familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
• Ability to work creatively and analytically to balance multiple priorities, tasks, and sophisticated issues using logical and efficient processes

Preferred:

• Advanced Education and/or Certifications
• Prior Consulting experience
• Experience with scientific, medical, or technical writing

Compensation:

The targeted gross compensation range for this position is between $65,000.00 and $95,000.00 annually. Please note: this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.

Halloran Benefits and Perks:

The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. We offer reimbursements for Health & Wellness Programs and Memberships, opportunities for continued learning through conference and continuing education programs. We also offer a Self-Managed PTO Policy, Commuter FSA Benefits, and many other benefits.

Halloran Consulting Group, Inc. COVID-19 Considerations:

Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering Halloran’s offices, attending Halloran sponsored events (at Halloran offices or otherwise), and traveling to client sites, subject to requests for accommodation. Individuals will be considered fully vaccinated two weeks after a second shot of a two-shot vaccine regimen (i.e., Pfizer or Moderna) or two weeks after a single shot of the Johnson & Johnson vaccine.

Notice:

Halloran does not sponsor visas for employees.

All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.

Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws).

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by an authorized representative of Halloran.