GMP Support Associate Contract

The Scientific Team at Russell Tobin & Associates is supporting a world-class biotech/pharmaceutical client in San Francisco, CA with a GMP Support Associate opportunity!

Responsibilities

• Support strategic plans for GMP vendor compliance in accordance with Pharmacovigilance (PV) Vendor compliance per health authority requirements.
• Support team Lead on operations performed (policy and procedure implementation)
• Training coordination
• US complaints management – product complaint intake and quality record processing per Quality global/local SOPs, initiation, and reconciliation of Medical Product Complaints (MPCs), Technical Product Complaints with Special Situations, and Post Marketing Reportable Events (PMSRs)
• Support US Call Center training, documentation, QC and issue resolution

Requirements

• Bachelor of Science degree (Life Sciences)
• 2+ years PV/GMP or compliance-related experience
• Knowledge of FDA GMP safety regulations, ICH guidelines, and other applicable regulatory guidance documents
• Good computer skills
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Additional Details:

• Position Type: 1 year contract opportunity with potential for extension
• Pay rate range: $40-46/hr (may be flexible for the right experience)
• W2 position
• Must be eligible to work in the United States. Unable to provide visa sponsorship now or in the future.

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