Job description
We are currently looking to fill a Quality Assurance Specialist (Drug Product) positions. This position will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility.
- Monday-Thursday, 3rd shift
- Wednesday-Saturday, 1st shift
- Tuesday-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.
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Salary Range (annually)
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