Quality Specialist II, Process Validation Chemist (On-Site)

Purdue Pharma L.P. is seeking a Quality Specialist II, Process Validation Chemist to perform various chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures.

Requirements

• Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
• Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Operate and maintain all analytical instrumentation and equipment as per established procedures.
• Write, revise, develop and evaluate operational and maintenance procedures.
• Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
• Provide training and assistance to other group members.
• Actively participate in investigations, problem solving and troubleshooting.
• Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
• Re-stock chemicals and consumables used in analysis.
• Prepare and present data summaries (written and oral) as necessary.
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
• Exercises good judgment in interpreting, understanding context, and reporting data.
• Proactively identifies potential problems and recommend solutions.
• Prepares, writes, and distributes reports as appropriate.
• Participates in preparation and revision of job related controlled documents.
• Performs analytical testing of samples under limited direction.
• Skilled with laboratory equipment, including routine maintenance and calibration.
• Proficient with use and understanding of laboratory chromatography software.
• Perform other related assignments and duties as required and assigned.

Benefits

• 401k Matching
• Relocation Assistance