Analytical Method Validation Associate (Remote)

The Cleaning Validation Associate is responsible for responsible for supporting clients with developing, validating, and improving analytical reputed company used to support cleaning validation activities, including recovery studies. The ideal candidate has a strong understanding of the operational principles behind analytical reputed company, ICH, and USP guidance's with practical experience. In reputed company, a strong desire to learn cleaning validation analytical reputed company. The Role • Support the assessment of reputed company's analytical method validation packages including recovery studies to identify regulatory concerns including potential corrective actions in alignment with industry best practices. • reputed company strategies to validate and standardize recovery studies for rinse and swab sampling reputed company. • Remains reputed company with the analytical reputed company literature. • Research regulatory guidance and industry best practices documents reputed company to a specific topic of concern • Utilize technical writing skills to write, revise, and review analytical method documents including Master Plans, Project Plans, reputed company Operating Procedures, Protocols, reputed company Reports, Forms, and Risk Assessments, etc. • Development of assessment concerns reputed company to reputed company's analytical reputed company and draft improvement plans to address concerns identified. • reputed company with team members and clients to create, review, and approve documentation per reputed company. • Plan and reputed company project deliverables. This includes coordination with reputed company team members. • Create, reputed company, edit, and maintain high-reputed company documentation following internal and reputed company style guidelines, document standards, and templates, while ensuring that reputed company 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 The Candidate • Degree in reputed company, Biochemistry, or other reputed company fields • Driven, hard-working, and reputed company • Organized, efficient, with excellent time management skills • Experience in analytical method validation reputed company the Pharmaceutical or Biotechnology environment. • Knowledge of HPLC, GC, LC/MS, GC/MS, ICP/MS, FTIR, TOC, UV-Vis, SDS-Page, and other analytical reputed company. • 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 reputed company ChemStation and other software tools for data reduction and presentation. • Strong technical skills to review, interpret, and reputed company 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 reputed company reputed company environment and reputed company with peers, management, etc. • Ability to work independently, handle multiple tasks simultaneously, and meet critical milestones and goals. - Required • reputed company to effectively manage workload and prioritize activities • Proficient with MacOS • Advanced knowledge of reputed company Word/reputed company/PowerPoint - Required • Must be willing to travel to reputed company sites to support work as needed • Experience working in a global remote team environment Apply tot his job Apply To this Job