Specialist QA-34383
Specialist QA-34383
Posted on :
05-07-2025
Employer Active
1 Vacancy
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Job Description
Summary:
Perform one or more of the following duties and responsibilities in support of Amgens Quality Assurance program under minimal supervision.
Functions:
Education:
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.
- Science or Engineering bachelor.
- Pharmaceutical environment experience.
- Spoken languages: Spanish and English.
- Experienced quality assurance specialist.
- Commissioning and Qualification of Equipment/Systems/Facilities.
- Auditing Equipment/Facilities/Utilities of Qualification Protocols and execution.
- Revision and approvals of technical documents like URS Design Report of technical data.
- Deep knowledge of quality assurance terminology methods and tools.
- Knowledge on Veeva CDOCS applications.
- 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.
- 100 % On-Site
- 12 months (1st Contract)
- Administrative Shift(weekends and overtime may also be required).
- Professional Services Contract
Required Experience:
Unclear Seniority
Employment Type
Full Time
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