Quality Control Specialist

Role Summary

The Sr. Specialist of Quality Control oversees contract organization method development in support of product release, process development and stability. This role is responsible for implementing and developing quality control expectations on investigational products and commercial operations, including analytical development and assay troubleshooting. It supports analytical development, product release, stability trending, and adherence to ICH guidance within internal and contract quality systems.

Responsibilities

• Oversee the implementation of general laboratory operational systems and testing capabilities, related method development, transfer and qualification activities, investigations, data trending and assay/instrument troubleshooting
• Support the development and implementation of new analytical methods as required to meet quality attributes
• Oversee the in-process and release product testing in support of manufactured drug substance and drug product to ensure the product meets quality attributes performed at contract organizations
• Collaborate with the other Quality and functional area to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate
• Provide support for the appropriate strategic planning for continuous improvement and reporting/escalation of issues and/or risk mitigation activities to ensure a culture of quality and compliance
• Oversee product stability studies aligned with ICH guidelines to support shelf life and product retest assessment
• Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

Qualifications

• At least 6 years of cGMP QC experience in biotechnology/large molecule and small molecule industry with QC principles, USP/Ph Eur compendia testing requirements; with various analytical and biochemical testing techniques
• Experience in analytical method development, validation and transfer
• Technical expertise in analytical platforms
• Scientific technical writing ability for technical reports, SOP or other processes to support regulatory compliance

Education

• Bachelor's degree in Chemistry, Biochemistry, or a closely related field

Additional Requirements

• Ability to travel 20% of the time