Ideal candidate is available to work the following: Wednesday, Thursday, Friday, 9PM - 9AM.
- Performs batch record preparation, issuance, batch record review and disposition.
- Issuance of controlled labels and forms.
- Ensures full GMP compliance for the disposition of raw materials and components.
- Tracks and trends deviations, non-conformances, corrective actions, OOS, change controls, investigations and other metrics in support of management review.
- Review and approve qualification and validation protocols and reports.
- Provide oversight of the change control technical assessment/evaluation process and manage escalation of changes beyond site.
- Conduct product complaint investigations
- Provides support in one or more of the following:
- Review and approval of change controls.
- Investigation and recall of non-conforming materials.
- Investigations associated with product failures, product complaints and BPDRs.
- Review and approve GMP facility work orders and validation activities
- Support FDA/Regulatory Agency inspections
- Represents department in cross-functional teams, projects and GXP-related problem resolution.
- Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
- Some travel may be required.