Document experiments in compliance with sops and alcoa+
The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies
Job Summary
The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies.
In your role as Senior Specialist, you will be part of a cross-functional team providing analytical support towards release of raw materials and package components.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Matching Summary
The primary objective of the SMAR&D GxP Operations team is to carry out analytical GMP activities partnering across the network to enable clinical supplies.
Salary
$106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
GMP analytical activities
Excipient and package component release testing
Document experiments in compliance with SOPs and ALCOA+
Data review of laboratory notebooks
Troubleshoot and lead investigations
cGMP audits or inspections
Nice-to-have
Hands-on experience in GMP operations
Experience with electronic notebooks
Experience with SAP QN
Key Requirements
Minimum 5 years relevant industry experience (BS)
Minimum 2 years relevant industry experience (MS)
Excellent written and oral communication skills
Work in a team environment
Strong lab OOS investigation and trouble shooting skills