Specialist Qa - 29689

Specialist Qa - 29689
Empresa:

Cis International Llc


Specialist Qa - 29689

Detalles de la oferta

Description:
Perform one or more of the following duties and responsibilities in support of 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.
Education:
Master’s degree in Sciences/Engineering and 3 years of Quality experience or Bachelor’s degree in Sciences/Engineering and 5 years of Quality experience.
Preferred Qualifications:
Experience in Quality Assurance, and / or Aseptic processing preferred. Good decision making skills, and self-starter.
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 Values/Leadership Practices.

Job Type: Full-time
Salary: $0.00 /hour
Experience:
Aseptic processing: 5 years (Preferred)
Quality Assurance: 5 years (Preferred)

Education:
Bachelor's (Preferred)

Schedule:
Other

Requisitos

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