Specialist QA (Deviations) Administrative Shift- 34374
Specialist QA (Deviations) Administrative Shift- 34374
Posted on :
15-06-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Summary:
Perform one or more of the following duties and responsibilities in support of Amgens Quality Assurance program under minimal supervision.
Functions:
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.
- Associates 8 years of directly related experience.
- Educational background in Life Science and/or Engineering.
Preferred Qualifications:
- Expertise in Quality Systems such as Deviations (Non-conformities CAPA and Change Control).
- Hands on experience in electronic systems for instance: Documentation platforms (CDOCS) Maximo Trackwise LIMS electronic batch record (MES) and SAP.
- Experience with Validation of GxP applications Validation Master Plan Installation Qualification (IQ) Risk Assessment/GxP assessment Operational Qualification (OQ) and Performance Qualification (PQ) Protocols Test Scripts and Completion/Summary Reports approvals as per the compliance requirements.
- Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications.
- Enhanced skills in leading influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
- Strong communication (both written and oral) facilitation and presentation skills. Fully Bilingual in English and Spanish.
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
- 6 months (1st Contract)
- Administrative Shift (weekends and overtime may also be required).
- Professional Service Contract
Required Experience:
Unclear Seniority
Employment Type
Part-Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
