Description:

• Perform one or more of the following duties and responsibilities in support of Company's Quality Assurance program under minimal supervision.

Functions:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Education: 

• Doctorate degree or Master's degree and 3 years of directly related experience
• Bachelor's degree and 5 years of directly related experience \
• Associate's degree and 10 years of directly related experience
• High school diploma / GED and 12 years of directly related experience.

Preferred Qualifications: 

• Preferred Experience in Quality Assurance role
• Proficiency in Quality Management Systems
• Technical Skills in:
  • Inspection Processes (automatic and manual)
  • Equipment knowledge (engineering characterizations / system validations)
  • Data analysis
  • Manufacturing processes
  • Document review and management
• Soft Skills:
  • Attention to detail
  • Critical and Analytical Thinking
  • Cross functional collaboration
  • Strong communication

Competencies/Skills

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Companys' Values/Leadership Practices.

Work Methodology:

• 100%-On Site
• 5 months (1st Contract)
• Administrative Shift  (Available to work weekends.)
• Professional Service Contract