Product Specialist jobs in Nassau, NY

Available Work Schedules:

• Wednesday-Saturday, 1st shift

• Monday-Thursday, 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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