QC Analyst , Chemisty
Raleigh Metro Area, NC
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. The analyst will be responsible for ensuring that the samples are collected, tested and reviewed according to quality requirements and results reported are valid, accurate and documented per applicable regulatory and corporate requirements.
Performs testing and associated tasks without errors per applicable SOPs and protocols.
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in lean lab operation, 6S laboratory layout, KATA, preventive action & continuous improvement programs to reduce operating costs
Performs shift-work as necessary to support manufacturing
Participates and performs in cross-training to support staff availability within QC department
Develops and maintains SOPs
Develops expertise in assigned assays/techniques
Authors deviation and invalid assay assessments
May be required to perform shift work as required to support operation
HPLC/UPLC, UV, FTIR, raw material testing, compendial testing
0-2 years of laboratory experience OR equivalent
Knowledge of GMPs, safety regulations and data integrity
Knowledge of analytical methods and related instrumentation.
Bachelor s degree in Scientific discipline and 0-2 years industry experience or equivalent