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Sr. Quality Assurance Manager
Assist with the monitoring, managing and improvement of the quality system; ensures that the quality system meets regulatory compliance requirements.
Manages the approved supplier list (ASL); assists in performing audits of key suppliers and contract laboratories, and performs trending of suppliers.
Responsible for the development of and approval of quality control and inspection plans; review and approval of master batch records; and review and approval of validation protocols and reports.
Responsible for the incoming inspection; in-process monitoring and inspection of the manufacturing process; review and approval of executed batch records; approval of final product disposition; and performs product trending.
Manages the investigation of product field issues to include complaints and returns; ensures proper documentation of complaint analysis and failure investigation; performs trending on product complaint and failure investigations.
Skills and Abilities
Will possess a thorough knowledge of quality system requirements per cGMP, QSR and ISO, and the ability to audit per these requirements.
Should display sound judgment practices.
Must be proficient in complaint handling and reporting requirements.
Ability to perform in a team environment as well as an individual contributor.
Strong written and oral communication abilities.
Must be able to visually inspect/examine products (and/or use appropriate measuring devices), components and written material.
Extensive interaction with all facility/company personnel (Manufacturing, R&D, Materials/Planning, Customer Service, HR).
Interaction with suppliers, customers, and sales representatives.
B. S. Science or Equivalent
Strong Background in Chemistry preferred
Minimum seven (7) years quality experience, preferably in the pharmaceutical industry.
Must have experience with cGMPs, QSR and ISO 13485 regulations.
Must have a thorough knowledge of quality system requirements.
Must have thorough knowledge batch record requirements.
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