Quality Control Specialist Jobs

Title:

Quality Control Specialist

Company:

Ipsen Bioscience, Inc.

:

Summary

IPSEN Cambridge Manufacturing site, MA is seeking an experienced QC Specialist with HPLC / Chemistry and microbiology background. The QC Specialist is responsible for supporting Quality Control testing of drug product and QC analytical activities outsourced to contract testing laboratories. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, troubleshoot and manage optimization projects.

Primary Responsibilities

• Train and guide laboratory personnel on test methods and lab procedures.
• Lead quality systems investigations, OOS/OOT investigations and CAPAs.
• Sampling raw materials and manage sample send outs
• Perform in-process product testing and review of in-process, external lab data, release under cGMP.
• Review and revise QC SOPs
• Troubleshoot aberrant data
• Ensure GMP compliance in the QC lab.
• Review and release QC test data.
• Maintain laboratory and inventories for supplies along with preparation of reagents/ buffers.
• Conduct environmental monitoring/micro activities including EM sampling, water testing, growth promotion
• Work with external labs sending out samples, tracking testing.
• Support the general lab cleanliness and compliance.
• Manage Quality related projects

Additional responsibilities include

• Support training system administration
• Administrative support for Easidoc system

Knowledge, abilities and Skills

• HPLC / Chemistry and Microbiology QC experience
• Understanding of FDA, EMA and ICH quality requirements
• Strong organization and multitasking ability
• Demonstrated ability to work in a team environment
• 3 + years’ experience in a QC laboratory GMP environment
• Bachelor’s degree in science. Chemistry, Biochemistry or Microbiology preferred.
• Excellent written and oral communication

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.