Date Posted: November 07, 2016
Employment Type: Direct Hire
Job Id: 7245
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.