We are currently looking to fill multiple Quality Assurance Specialist (Drug Product) positions. These positions will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility.
Available Work Schedules :
Wednesday-Saturday, 2nd shift (4x10)
Monday-Friday, 2nd shift
In this role, a typical day might include the following :
Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team.
Perform assessments of existing procedures / documents to gauge appropriateness for the inclusion of drug product operations;
where current documents are not adequate, identify path forward for establishment of procedures
Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
Accountable for maintaining project timelines to support the evolving business
Perform On-The-Floor quality review of documents, such as : equipment logs, training records, testing results, batch records and supporting documents.
Review and approval of documents (electronic and paper-based)
Execute daily operations per management in a multifaceted environment.
Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
Provide mentorship during on-the-floor manufacturing
Support audits, inspections and investigations
Perform quarantine, segregation of material and line clearances
Contribute to the continuous improvement initiatives
This role may be for you if you :
Are able to adjust schedule based on facility start up, filling, and manufacturing needs.
Possess the ability to multi-task / own multiple projects while ensuring each is progressing as planned against defined timelines
Are good at establishing relationships and working / collaborating on cross functional teams
Can develop performance measures and reports to be presented to management which demonstrate progress and status of projects
Are able to gown for an A classification work environment
To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and following minimum amounts of relevant experience for each level :
Associate QA Specialist 2+ years
QA Specialist 4+ years
Sr QA Specialist 6+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
REGNQA
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