Quality Assurance Associate
($70-$80k/year)
ABOUT THE COMPANY
This is a global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for the general population.
ABOUT THE ROLE
The Quality Assurance Associate provides support to all functions within the Global Quality department. With a solid foundation in QA, they are expected to be flexible and nimble in their role to manage short and longterm projects as well as dealing with day-to-day QA tasks.
The Quality Assurance Associate will interact closely with the Commercial Affairs and Clinical Affairs departments and local GMP/GDP service providers to ensure the required pre and post-marketing compliance level is achieved and maintained. The role is based in Burlingame, CA and some travel may be required. Working across the global business as part of a high performing team, there is an expectation of out-of-hours flexibility to deliver on projects.
ESSENTIAL REQUIREMENTS FOR ROLE
* Bachelor's degree in Chemistry, Pharmacy, or related life science major preferred
* Experience with GMP and GDP Operational Quality Systems for Commercial Drug Product
* Distribution Supply Chain Operations experience
*Relevant experience in a pharmaceutical or other life science organizations
* Experience in utilizing quality system processes (such as Audits, Deviations, CAPA, Change Control)
* Good experience of articulating and implementing SOPs & quality documents
* Ability to clearly and concisely communicate technical information
* Studious, active mind, willing to acquire knowledge * Ability to research, analyze and report independently across a breadth of topics
* Excellent administrative and people skills, and ability to work autonomously
* Ability to work under pressure and flexibility to adjust course when required
* An inquisitive mind, unafraid of scientific information or new concepts
* Excellent communication and organizational skills
