QC Laboratory Associate Scientist Consultant

Full Time Contract Title: QC Laboratory Associate Scientist Location: Onsite Barceloneta, PR Length of Contract: 12+ months Position Description:
RCM is looking for a QC Laboratory Associate Scientist for analytical methods and laboratory compliance. Will focus on the why behind the data: investigating OOS (Out of Specification) results, managing method transfers, and ensuring the lab remains in a state of constant audit-readiness.
Responsibilities
+ Laboratory Investigations: Drive Phase I and Phase II investigations for OOS, OOT (Out of Trend), and atypical results using Root Cause Analysis (RCA) tools.
+ Method Lifecycle Management: Oversee the performance of validated analytical methods (e.g., HPLC, ELISA, Bioassays) and manage technical transfers from R&D to the PR site.
+ Regulatory Audit: Act as the primary technical contact during FDA, EMA, and PRDOH inspections, defending laboratory data and investigation reports.
+ Change Control Oversight: Support an...