Act as QA Operations Shop Floor Lead by assuring products manufactured are in compliance with corporate, regulatory and industry standards through oversight of operational documentation and routine quality inspections, and supporting deviation investigations that occur during operations. Ensure continual process improvements within operations to drive reduction of deviations and improve process throughput.
Technical Perform activities that ensure required quality and safety standards are being met for our products and processes.
Acts as the QA Shop Floor technical Shift Lead and assume duties as directed/required.
Coordinate the daily shop floor tasks for the specified shift to ensure that production lines operate according to applicable SOPs, quality standards, and defined production schedules.
Ensure quality information is collected and recorded accurately and timely (e.g, MBRs, test results, logs, etc). Ensure all data integrity requirements are followed by operations and support staff.
A thorough understanding of all aspects of the manufacturing facility, process, procedures, and equipment is required. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions through risk-based decision making.
Assist on investigations related to quality deviations and review investigation reports. Excellent technical writing skills.
Review and approve fill room critical alarms.
Review and approve revisions to SOPs and MBRs.
Lead or participate in operational excellence projects or other cross functional projects/teams to support business goals and gain a wide variety of experience.
Participate in internal and external audits.
Team Cooperate and support coworkers to enhance overall capability of the organization.
Train and coach associates.
Coordinate shop floor tasks with other team members to ensure work assignments are carried out timely and effectively.
Collaborate with other QA Shop Floor shift leads to ensure department and production goals are being met.
Lead daily Tier One meetings with QA Operation Shop Floor Team.
Work cohesively with and support collaboration and training needs of team members.
Act as a role model for company values and behaviors.
Mentor associates in own department or other departments.
Interfaces Coordinate with other departments to accomplish objectives.
Partner with Operations teams to optimize quality and efficiency across the site.
Assist Production, Engineering, and MS&T to troubleshoot quality problems.
Work with Material Control to identify, locate, and hold production lots, as needed.
Communicate trends and potential issues to upper management and internal department.
Effective presentation skills in one-on-one, groups, peers, and upper management settings.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum Education / Experience:
High School diploma with 2+ years experience in Quality Assurance, in a regulated environment within the pharmaceutical, Medical Device or Biotechnology industry
Must be fluent in English
Preferred Education / Experience: Bachelor of Science in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field.
5+ years experience in a GMP regulated environment within the pharmaceutical, Medical Device or Biotechnology industry with Root Cause investigation, regulatory compliance understanding, internal or external audit experience, risk management.
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