Specialist QA- 3rd Shift Warehouse, Incoming- CAPA - 33823

Description:

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

• 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.

• Doctorate degree.
• 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.

• Knowledge in Warehouse and Incoming QC operations, in quality oversights, in quality records such as deviations, CAPAS, change controls, and data integrity concepts.

• 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 Company's Values/Leadership Practices.

• 100% On-site
• 3 years
• 3rd Shift (9:00pm to 5:30 am)
• Professional Services Contract