Quality Control & Quality Affairs (QC/QA) Associate II

Quicksilver Scientific•Louisville, CO

6d•Hybrid

About The Position

Quicksilver Scientific is seeking a motivated Quality Control & Quality Affairs (QC/QA) Associate II to join their team. This role involves overseeing quality control in manufacturing and bottling operations, managing product and customer complaints, and ensuring compliance with regulatory standards. The position is based in a clean, regulated manufacturing environment and an office, with occasional warehouse work. The company is committed to supporting employee health, well-being, and professional growth.

Requirements

Applied Science or an Associate's degree in a comparable field
2 years of experience in a comparable field
2 years of cGMP experience
MS Office Suite-intermediate skill level
Must be able to walk, bend, stoop, and operate instrumentation requiring hand dexterity.

Nice To Haves

3+ years of cGMP experience
Bachelor's degree in a comparable field
Experience with finished product testing and sampling
Experience with 21 CFR Part 111 Dietary Supplements
Technical writing experience (SOP, Regulatory submissions, technical reports)

Responsibilities

Oversee production line clearances for both manufacturing and bottling operations.
Ensure timely batch release, providing back-up support as needed.
Review and approve document change requests.
Maintain accuracy in part number assignment.
Support the initiation, investigation, and resolution of complex deviations and CAPA reports.
Design, support, and maintain the retention sample program, ensuring on-time finished product testing.
Conduct label review and inspection to ensure compliance and accuracy.
Support final product and raw material testing and release processes.
Manage and monitor equipment calibration activities.
Perform environmental monitoring, including monthly air, plate, and water sampling in manufacturing, bottling, and RO water systems.
Manage product and customer complaints, including initiating and leading investigations through resolution.
Maintain and administer the supplier qualification program.
Support additional QA responsibilities as assigned.