Job Details

The Cleaning Validation Associate is responsible for responsible for supporting clients with developing, validating, and improving analytical methods used to support cleaning validation activities, including recovery studies. The ideal candidate has a strong understanding of the operational principles behind analytical methods, ICH, and USP guidance's with practical experience. In addition, a strong desire to learn cleaning validation analytical methods.

The Role

• Support the assessment of client's analytical method validation packages including recovery studies to identify regulatory concerns including potential corrective actions in alignment with industry best practices.
• Develop strategies to validate and standardize recovery studies for rinse and swab sampling methods.
• Remains current with the analytical chemistry literature.
• Research regulatory guidance and industry best practices documents related to a specific topic of concern
• Utilize technical writing skills to write, revise, and review analytical method documents including Master Plans, Project Plans, Standard Operating Procedures, Protocols, Summary Reports, Forms, and Risk Assessments, etc.
• Development of assessment concerns related to client's analytical methods and draft improvement plans to address concerns identified.
• Interact with team members and clients to create, review, and approve documentation per timeline.
• Plan and track project deliverables. This includes coordination with internal and external team members.
• Create, develop, edit, and maintain high-quality documentation following internal and client style guidelines, document standards, and templates, while ensuring that quality targets, timelines, and regulatory requirements are met.
• Manage and organize project documents
• Look for ways to continuously improve generated documentation
• Communicate effectively with team members and external vendors/clients
• Other duties as assigned by the manager

• Degree in Chemistry, Biochemistry, or other related fields
• Driven, hard-working, and determined to succeed
• Organized, efficient, with excellent time management skills
• Experience in analytical method validation within the Pharmaceutical or Biotechnology environment.
• Knowledge of HPLC, GC, LC/MS, GC/MS, ICP/MS, FTIR, TOC, UV-Vis, SDS-Page, and other analytical methods.
• Working knowledge of cGMP/GLP requirements, ICH, FDA, USP, and other pharmaceutical industry regulatory guidelines is highly desired.
• Experience with rinse and swab sampling recovery studies
• Experience in the operation of chromatographic data acquisition and processing software packages such as Agilent ChemStation and other software tools for data reduction and presentation.
• Strong technical skills to review, interpret, and make scientific conclusions and recommendations based on data
• Experience in the operation, minor maintenance, troubleshooting, and calibration of laboratory equipment preferred
• Ability to understand and extract necessary information from technical documents
• Technical writing experience
• Excellent grammar and writing skills - Required
• Effectively work within a team environment and interface with peers, management, etc.
• Ability to work independently, handle multiple tasks simultaneously, and meet critical milestones and goals. - Required
• Able to effectively manage workload and prioritize activities
• Proficient with MacOS
• Advanced knowledge of Microsoft Word/Excel/PowerPoint - Required
• Must be willing to travel to client sites to support work as needed
• Experience working in a global remote team environment