Analytical Method Validation Associate
Analytical Method Validation Associate
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Job Description
Job Title: Analytical Method Validation Associate
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Entry level
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 highquality 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
The Candidate
- Degree in Chemistry Biochemistry or other related fields
- Driven hardworking 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 UVVis SDSPage 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
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Employment Type
Full Time
