Senior QC Associate NPI

  • Nationwide
  • Temporary
  • JO-1711-63010_1510313389

Summary

Job Summary:

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

*Contributes to team by ensuring the quality of the tasks/services provided by self

*Contributes to the completion of milestones associated with specific projects or activities within team

This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Responsibilities

*QC Representative for NPI activites and routine Product meetings

*Assist with activities related to QC projects and/or QC tasks within Site projects

*Plan and Perform non-core testing related to NPI activites

*Manage all sample management activities related to NPI activites throughout the site

*Create/own and approve protocols, sample plans, SOP and documentation related to NPI

*Responsible for their own training and safety compliance.

*Sample shipments and temperature monitoring activities for NPI activites

*LIMS data coordination of non-core ( NPI) activites.

Specific Job Duties:

*With a high degree of technical flexibility, work across diverse areas within QC

*Plan and perform analyses with great efficiency and accuracy.

*Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

*Report, evaluate, back-up/archive, trend and approve analytical data.

*Troubleshoot, solve problems and communicate with stakeholders.

*Initiate and/or implement changes in controlled documents.

*May train others as necessary

*Participate in audits, initiatives and projects that may be departmental or organizational in scope.

*Write protocols and perform assay validation and equipment qualification/ verification.

*Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

*May contribute to regulatory filings.

*May conduct lab investigations as necessary.

*Evaluate lab practices for compliance on a continuous basis.

*Approve lab results

*May represent the department/organization on various teams

*May interact with outside resources.

*Create APPX data files and randomisation memo to facilitate data analysis.

*LIMS data coordination of commercial and import testing on site where applicable

*May provide technical guidance.

*May represent the department/organization on various teams. May train others.

*May interact with outside resources.

Requirements

*Bachelor's degree in a Science related field is required.

*5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,

*Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

*Communication skills (verbal and written) at all levels

*Decision Making skills

*Teamwork and Coaching others

*Negotiation and Influence skills

*Investigation skills

*Problem solving skills

*Project Management and organizational skills, including ability to follow assignments through to completion

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