Job Title: Senior Assoc
Key Responsibilities:
- Compile and report on Quality metrics, as well as lead presentations that identify trends and risks, and make recommendations
- Collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Plan and coordinate routine and non-routine projects requiring independent judgement, evaluation and selection of compliant scientific techniques
- Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR
Qualifications:
- 6-8 years related experience in a pharmaceutical manufacturing environment
- Knowledge of Trackwise to handle eQMS data
- Strong knowledge of microbiology testing
- Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
- Familiarity with regulatory / compliance environment (cGMP, GLP) associated with drug manufacture
