Compliance Specialist consultant
Rensselaervle, New York (Onsite)
Long term contract
No H1b visa
Job Description.
A large pharmaceutical company based in New York is in immediate need of a Compliance Specialist consultant to join the External Manufacturing Compliance team for a 12-month project (potential for extension past 12 months). The project will need to be completed while working every day on-site.
The company is growing is very quickly and this consultant is needed to support an increase in workload. The client outsources multiple functions to external partners for filling, packaging, etc. and also for drug substance, the Compliance needs to ensure anything coming from CMOs meets requirements or if anything needs to go through the Change Control process. The Consultant will need to be an expert working within Quality Systems as an owner of Change Control, Deviations, and CAPA records.
Project Scope:
Own and manage External Manufacturing items through Quality System including Change Control proposals, CAPAs, and SCARs for clinical and commercial external mfg.
Collaborate across the department and partner with External Manufacturing Operations relationship leads
Facilitate meetings to manage priorities and ensure current status updates
Contribute to improvements in External Manufacturing department SOPs. May lead reviews, audits for compliance, and revisions of SOPs
Top Requirements:
BS degree minimum
Minimum 5 years of experience working in Pharmaceutical industry
Strong communication and technical writing skills
Experience interacting with CMOs or other external groups like corporate partners, preferably in an External Manufacturing or QA role
Experience authoring, reviewing, or auditing operations against SOPs is preferred
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