Costa Mesa
🔹 Responsibilities:
* Review executed batch records and supporting documentation for completeness, accuracy, and complianc
e
* Support product release activities and ensure adherence to cGMP, GDP, and ALCOA+ principl
es
* Review deviations impacting batch quality and assist with CAPA activit
ies
* Maintain quality documentation and support audit and inspection readi
ness
* Identify process improvement opportunities and contribute to quality initia
tives🔹 Qualificat
ions:
* Bachelor's degree in a scientific discipline preferred (or equivalent exper
ience)
* 2-4 years of QA experience in a GMP-regulated envi
ronment
* Experience reviewing batch records and supporting product release ac
tivities
* Working knowledge of FDA, EMA, and cGMP req
uirements
* Familiarity with quality systems including Deviations, CAPA, Change Control, and Docume
nt Control
* Strong attention to detail, organizational skills, and documentatio
n practices🔹 Ideal
Candidate:
✔ Experience in pharmaceutical, biotechnology, manufacturing, or other regulate
d industries
✔ Strong understanding of quality systems and compliance
requirements
✔ Ability to work independently and manage prioriti
es effectively
✔ Commitment to quality, integrity, and continu
ous
improvement...