Batch Record Designer / Author

Duties and Responsibilities: 

We are looking for a Recipe Designer with broad expertise in design of structured master batch records in Life Sciences Industries and FDA regulated areas.  The role will be focused in two major areas: establishing batch record standards that include process improvements and migration of the new standardized records from a paper based system to a fully Electronic Batch Record system.   While knowledge of Electronic Batch Record systems is desirable the most critical capability we are seeking is a complete understanding of authoring process and experience in developing batch record standards. 

Basic Qualifications

The successful candidate will have:

• 
  
  Minimum of 5 years experience in the Life Sciences industry with GMP / Pharma environment and Pharmaceutical process knowledge
  
  
• 
  
  Detail knowledge of pharmaceutically relevant data: the input material list, valid SOPs, detailed work instructions to be applied in production, and also process data, or process steps, such as in-process controls (IPCs), Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). 
  
  
• 
  
  Proficiency with common technical writing & publishing tools; Microsoft Word, Excel & Visio.
  
  
• 
  
  Practical knowledge to develop and build documents within a library of work instructions (building blocks) that contains variable parameter fields for process or product specific information Knowledge of ISA88 and Batch Record Design Processes

Must have

• 
  
  3+ years solid experience in Batch Record Design or Authorin
  
  
• 
  
  Be able to work under pressure and meet tight schedules
  
  
• 
  
  Have Good communication and interpersonal skills
  
  
• 
  
  Have good command of spoken and written English as well as Spanish

In addition you will have demonstrated analytical, conceptual and problem solving skills, and a demonstrated ability to work as part of a multi-disciplinary team.

Pluses include:

• 
  
   Expertise in multiple regulated manufacturing environments such as Solid Dose, Liquids, Aseptic, Biologicals, Generics, etc.
  
  
• 
  
  Experience in standardization methodologies, especially in the area of batch records
  
  
• 
  
  Experience in Electronic Batch Record systems such as  RSPMX,  WERUM,  Camstar  MES products
  
  
• 
  
  Experience with software development in FDA regulated environment and knowledge of pharmaceutical production management systems (ERP/MES)

LifeStyle

The work location will be in the Metro area with some limited travel to the mainland for planning meetings.   The work will focus on a single site but over time multiple sites will be included in the project.

If interested in being considered, please send your resume including salary history to

HR@Endeavorcg.com or Fax: 1-215-689-4331