Within this role you will be responsible for coordination and completion of manufacturing deviations and change controls.
As an Associate / Compliance Specialist a typical day might include, but is not limited to, the following :
Coordinating and documenting of manufacturing quality events including but not limited to deviations and change control’s
Coordinating cross functional teams during Change Control / Deviation events and align team on approach forward
Utilizing problem solving methodologies such as fishbone, 5 Whys to establish root cause of deviations
Working closely with Manufacturing Managers to review and evaluate quality event information
Assessing event for impact to SISPQ, conduct risk assessments and initiating appropriate corrective actions to prevent recurrence
Coordinating of internal reviews of investigational reports
Participating in management meetings to update leadership on current status of quality events
Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
Tracking and supervising manufacturing's open compliance records
Participating in regulatory and customer audits
This role might be for you if :
You thrive in a multifaceted and fast-paced environment
You possess excellent verbal and written communication skills
You enjoy problem solving
You successfully build and develop strategic partnerships
You demonstrate an ability to work within a successful team
To be considered for this opportunity you should have a BS / BA in Life Sciences or a related field and 2+ years of relevant work experience.
Relevant experience may be substituted in lieu of educational requirement.
IRELIM#JOBSIEST #LI-Onsite # REGNIELSM
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As an Associate / Compliance Specialist a typical day might include, but is not limited to, the following:. Tracking and supervising manufacturing's open compliance records. Within this role you will be responsible for coordination and completion of manufacturing deviations and change controls. Coor...
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