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Deviation Investigator Job

Eingestellt von Yoh

Gesuchte Skills: Engineering, Client

Projektbeschreibung

A DEVIATION INVESTIGATOR is needed for a long-term contract opportunity with Yoh's client located in Holly Springs, NC.

The Big Picture - Top Skills You Should Possess:
- Quality Assurance
- CAPA, Deviations, Investigations

What You'll Be Doing:
- The deviation owner will lead the investigation of deviations that occur in operations and are responsible for authoring the investigation
- Partner with quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions.
- Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations.
- Manage several investigations at a time.
- Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures.
- Determine appropriate preventative actions to prevent reoccurrence of the deviation.
- Author deviations and c onduct personnel interviews to determine root cause of the deviation.
- Close deviations in a timely manner to meet business and compliance needs.
- Work with minimal supervision to drive deviations to closure and implement CAPA's
- Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports
- Work with the Technical Services, Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and recommend product disposition.
- Present and defend investigations during regulatory inspections, as required
- Compile metrics and communicate results to the team and track status of deviations, CAPAs, change controls in Primary Manufacturing as required

What You Need to Bring to the Table:
- Minimum of five (5+) years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry
- Must have a thorough understanding of the pharmaceutical/biotech manufacturing process and equipment, preferably biopharm/vaccines,
- Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report

GET HIRED, APPLY NOW!

RECRUITER: Tonya Allen

Yoh, a DayJ2W: CLINICAL

MONJOB J2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Holly Springs, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh