Quality Compliance Specialist (Contract)

Description

• Assist with Inspection Readiness activities including the organizational inspection readiness across multiple projects in all stages of development or commercialization.
• 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.
• Input and maintain inspection ready information in the eQMS and SharePoint.
• Responsible for maintaining audit-related records throughout the program lifecycle.
• Conduct follow-up activities with internal stakeholders related to the inspection readiness program.
• Responsible for obtaining and compiling data relevant to risk assessments.
• Keeps Management informed of status of assigned projects. Knowledge/Skills:
• Assist in maintaining and developing standardized templates based on regulatory requirements and procedures.

Requirements

• Administrative experience in organizing and maintaining supplier and audit related records.
• Ability to contribute to the development of company objectives and key performance indicators.
• Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
• BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 1-3 years of related experience Experience:
• Minimum of 3 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
• Excellent attention to detail and organizational skills.
• Strong user of Microsoft Office applications.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Strong written and oral communication skills.
• 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.
• Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
• This position requires a knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Transportation benefits
• Medical, dental & vision
• Health Spending Account (HSA)
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Alameda,CA. Application Deadline This position is anticipated to close on Dec 24, 2025.

Training + Development

Interview process

Visa Sponsorship

Security clearance