Edison-New Brunswick Metro Area, NJ
To author, update and review SOPs, Analytical methods, laboratory record templates and logbooks in accordance with lab management oversite and strategy. Present authorship strategy to review board to get pre-approval and endorsement. Other writing tasks as applicable. May be required to support data mining activities and database establishment of existing raw data.
Ability to author technical scientific instructions independently whilst following instructions from governing SOPs
Exceptional ability to proof read and quality check controlled cGMP documents
Mastery of Microsoft Word and proficiency in Excel
Knowledge of cGMP requirements of an analytical laboratory from a document perspective
Interact with lab associates with multiple levels of experience in order to determine and rectify any issues/gaps within current documentation systems.
Ability to utilize custom programs or macros for drafting and archiving documents.
Demonstrate capacity to handle multiple document revisions and facilitate timely progress through the document revision cycle.
BSc, MS or PhD in either Immunology, Cell Biology, Molecular Biology or Virology or related discipline
1-4 years experience working as a lab associate in a QC laboratory