We are seeking to hire an Analytical Sciences Specialist to join our Analytical Sciences team…

If any of the below describes you, we would love to meet you!

JOB SUMMARY

The Analytical Sciences Specialist is responsible for supporting projects by developing and maintaining documentation and tasks required to fulfill project needs as well as auditing. This Specialist will work alongside Analytical Scientists to drive activities, accelerate timelines, offer ideas to implement future enhancements and efficiencies, and provide adequate quality oversight and expertise for the creation and review of internal quality documents.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

Lab Project Coordination

• Coordinate with the team across multiple projects to ensure that the timelines are met by communicating milestones and other deadlines within the projects.
• Implement procedural changes to existing internal systems to gain efficiencies to get products to clinical trial status earlier by working with Quality Assurance as well as other departments to implement change (i.e., participates in continuous improvement activities within the group).

Data Auditing Support

• Audit laboratory data for correctness, completeness, and compliance with cGMPs and the company’s internal quality standards (i.e., auditing laboratory data for early through late phase CTM and Registration batches).
• As part of the stability program, audit laboratory stability data and coordinate with the Stability Department to manage the stability testing schedule.
• Follow-up with Quality Assurance and Analytical Sciences staff to facilitate any corrections to data as required.

Lab Compliance Support

• Contribute to the creation and/or review of Quality and Regulatory documents, as needed.
• Managing the action items assigned to the group in various compliance documents (e.g., Change Controls, CAPAs, and Investigations). These activities include reviewing, follow up with the team, and approving action items until completion.
• Coordinate review and approval of various cGMP documents through the document management system (e.g., Test methods, SOP, Work Instructions, Controlled Forms, and CoA templates) to support Analytical Sciences processes

Other Support Activities

• Other miscellaneous tasks as required

REQUIRED SKILLS AND QUALIFICATIONS

• B.S. in Pharmaceutical Sciences, Biochemistry, Chemistry, Chemical Engineering, or a related discipline
• 3-5+ years of relevant industry working experience.
• Strong understanding of GMPs and associated FDA regulations
• A basic understanding of pharmaceutical formulation development
• A basic understanding of laboratory analytical equipment

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES