Specialist QA (12 hrs- Available Work AM & PM) 34622
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Summary:
Perform one or more of the following duties and responsibilities in support of Amgens 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:
- Masters 2 years of directly related experience.
- Bachelors 4 years of directly related experience.
Preferred Qualifications:
MES LIMS Maximo Batch Record Review experience.
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 Amgen Values/ Leadership Practices.
Work Methodology:
Perform one or more of the following duties and responsibilities in support of Amgens 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:
- Masters 2 years of directly related experience.
- Bachelors 4 years of directly related experience.
Preferred Qualifications:
MES LIMS Maximo Batch Record Review experience.
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 Amgen Values/ Leadership Practices.
Work Methodology:
- 100% On-site
- 3 years and 7months (1st contract)
- Shift: Non-Standard Shift (12 hrs: 5 am to 5:30 pm/ 5 pm to 5:30 am- available work: AM and PM).Weekends and overtime may also be required.
- Professional Services Contract
Required Experience:
Unclear Seniority
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
