Specialist QA

• 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.

• 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.

• Doctorate OR
• Masters + 2 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. OR
• Bachelors + 4 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. OR
• Associates + 8 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. OR
• High school/GED + 10 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation.

• Quality Professional with experience in Quality System and Validations.
• Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
• Available during weekends and holidays as requested, always available to be on site.

• Administrative Shift
• 1-year contract

BioPharma Consulting JAD Group