Quality Compliance Specialist

Quality Compliance Specialist

Onsite in Alameda, CA

Pay: $38 - $44.27/hr

Duration: 6 months, Contract, W-2

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Responsible for supporting GxP inspection and audit activities within the inspection readiness program, including audit preparation, audit closure, audit observation tracking, and records management.

* Administration and development of standardized templates based on regulatory requirements and procedures for inspection readiness and input information into the eQMS application.

* Ensure data in the Veeva audit module is up to date and accurate.

* Responsible for maintaining audit-related records throughout the program lifecycle.

* Responsible for obtaining and compiling data relevant to risk assessments.

* Assist with Inspection Readiness activities including the organizational inspection readiness across multiple projects in all stages of development or commercialization.

* Conduct follow-up activities with internal stakeholders related to the inspection readiness program.

* Input and maintain inspection ready information in the eQMS and SharePoint.

* Support internal and external stakeholders for monitoring supplier performance.

* Assist in tracking and trending of quality metrics related to the supplier qualification, audits and inspection programs.

Qualifications:

* BS/B.Sc preferably in the life sciences or STEM disciplines

* 3 years experience in biotech, pharmaceutical, or related industry.

* Knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.

* Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards. ISO understanding is a bonus.

* Must have excellent attention to detail and good investigation, problem solving, and organizational skills.

* Administrative experience in organizing and maintaining supplier and audit related records.

* Strong user of Microsoft Office applications.

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.