Quality Assurance Associate - FDA

This position is responsible to support the compliance of the Quality Management System with Regulatory requirements and internal processes. To ensure quality of products, components and/or operations using standard procedures (e.g. ISO 13485:13485, MDSAP, 21 CFR part 211, 820, 803, 806 etc.)

Typically responsible for the following duties:
* Verify UDI barcodes to ensure that the barcodes comply with FDA requirements
* Review and approve packaging/labels for all private label products to assure compliance with applicable regulatory requirements
* Represent Quality Assurance to support other departments with Quality and Regulatory issues/questions
* Participate in special projects and perform other duties as required

Other skills:
* Knowledge of FDA.
* Able to work independently.
* Effective verbal and written communication skills, excellent customer service background, data entry experienced.
* Able to follow written SOPs and formal procedural documents.
* Able to multi-task and handle multiple projects under pressure.
* Able to quickly process large volumes of administrative forms in an efficient manner with a high degree of accuracy and quality.
* Able to be flexible and change directions as necessary.
* Performs clerical functions, including but not limited to copying, filing, scanning, faxing, etc.
* Ability to follow instructions, superb attention to detail and, verbatim compliance to procedure.
* Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
* Perform moderate trouble shooting with minimal supervision.
* Ability to embrace change and participate in continuous improvement activity.

Preferred Education:
* Prefer 4-year college degree in science related field with 0-1 year Quality/Regulatory experience in the pharmaceutical or medical device industry.

Travel/Physical Demands:
* Office environment. No special physical demands required

Must Have
* Ability to maintain confidential information
* Ability to multi-task
* Ability to work in a team environment
* Able to follow written SOPs and formal procedural documents.
* Attention to detail and accuracy
* Computer Applications
* Customer service oriented
* Excellent time management skills and the ability to prioritize work
* Good written and verbal communication skills
* Interpersonal communication skills
* Plan and arranges activities
* Proficient in Microsoft Office and Adobe

Nice To Have
* Knowledge of ISO, FDA and able to work independently. Effective verbal and written communication skills, excellent customer service background, data entry experienced. Prefer 4-year college degree in science related field with 0-1 year Quality/Regulatory experience in the pharmaceutical or medical device industry.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.