Job Opportunities in United States
November 1, 2024
Weil Group, Inc
FULL TIME
Specialist QA(#16557886)
Temporary Job - initially for 2 yrs - 3rd shift (10pm-6:30am)
Are there specific educational/software requirements needed?
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Sciences is highly preferred
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
Preferably with knowledge in Warehouse and Incoming QC operations, in quality oversights, in quality records such as deviations, CAPAS, change controls, and data integrity concepts.
Description:
SUMMARY
Perform one or more of the following duties and responsibilities in support of Amgen'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/LICENSES
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
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 Client Values/Leadership Practices.
Job Type: Full-time
Expected hours: 40 per week
Benefits:
Are there specific educational/software requirements needed?
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Sciences is highly preferred
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
Preferably with knowledge in Warehouse and Incoming QC operations, in quality oversights, in quality records such as deviations, CAPAS, change controls, and data integrity concepts.
Description:
SUMMARY
Perform one or more of the following duties and responsibilities in support of Amgen'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/LICENSES
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
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 Client Values/Leadership Practices.
Job Type: Full-time
Expected hours: 40 per week
Benefits:
- Paid time off
- 8 hour shift
- Bachelor's (Required)
- Warehouse and Incoming QC operations: 5 years (Required)
- quality oversights: 5 years (Required)
- deviations, CAPAS, change controls & data integrity concepts: 5 years (Required)
- Bilingual (Preferred)
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