Specialist QA

Job details

Kelly Science & Clinical

is seeking

Specialist QA

for contract position at Pharmaceutical client in

Puerto Rico East area.

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/

REQUIREMENTS

- 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

-Candidates must be available for a 12 hrs. shift AM or PM, including weekends and Holidays.

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 Amgen Values/Leadership Practices.

What happens next:

Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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