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Specialist QA Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

SPECIALIST QA needed for a CONTRACT opportunity with Yoh's client located in W. GREENWICH, RI

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Medical device quality experience
- Biotech or pharmaceutical contract manufacturing quality experience
- Project management skills

WHAT YOU'LL BE DOING:

- Responsible for supporting all quality oversight functions related to medical devices manufacturing at contract sites manufacturing.
- Primary responsibilities of this position include change controls, complaints, CAPAs, and providing support with pre-approval inspection preparation.
- The primary driver is to support the increase in AMD quality workload for launch preparation.
- The position will support the current contract manufacturing quality staff focused on AMD with them with project management of contractor-initiated change controls, complaints, CAPAs, and Pre-approval inspection preparation.
- Responsible for ownership and management of quality change controls for the contract manufacturing of medical devices, and to ensure compliance is maintained and products manufactured to standards as part of change management.
- The scope of the changes will range from simple to complex process, production, and QMS changes.
- Facilitate conceptual buy-in process for proposed changes
- Manage the change implementation plan using input from the change sponsor and conceptual buy-in output
- Ensure that the documented change is accurate, complete, compliant, and handled according to Amgen's change control procedures and the change's agreed-to timelines.
- Manage adequate communication of tasks to task assignees, and reviewing/reporting task completion evidence into change control system
- Own and actively manage the change control record in change control system
- Responsible for ownership and management of product complaints assessments associated with contract manufactured medical devices.
- Managing contract manufacturers to provide timely investigations for failure identification and completeness of the assessment
- Make quality decision of acceptability and completeness complaint investigations from contract manufacturer
- Documenting complaint assessment investigation reports in the complaints database
- Providing investigation status updates to management
- CAPA updates where corrective action is required
- Some of these activities include communicating with the quality person stationed at the contract manufacturer facility.

WHAT YOU NEED TO BRING TO THE TABLE:

- Knowledge of process and faculty equipment, and the ability to interpret and apply Good Manufacturing Practices (GMP)
- Quality assurance or manufacturing experience in the medical device industry
- Written and spoken fluency required in specific language needed

RECRUITER:Mary Nguyen

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W:PROF

MONJOBJ2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    West Greenwich, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh