The Sr. Quality Specialist, Maufacturing Quality is responsible for performing a wide variety of QA activities to ensure compliance with applicable regulatory requirements.
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.
Bachelor’s degree in a scientific discipline or equivalent.
Proficient in MS Office applications.
10 years related experience in cGMP/FDA regulated industry.
Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.
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