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Description

The Compliance QA Specialist is responsible for supporting GxP inspection and audit activities within the inspection readiness program, including audit preparation, audit closure, audit observation tracking, and records management. As part of continuous improvement initiatives, they will assist in the administration and development of standardized templates for inspection readiness and input information into the eQMS application. In addition, they will be responsible for ensuring data in the Veeva audit module is up to date and accurate. ESSENTIAL DUTIES AND RESPONSIBILITIES: • 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. • Assist in maintaining and developing standardized templates based on regulatory requirements and procedures. • 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.

Skills

Quality assurance, Compliance, iso standards

Top Skills Details

Quality assurance,Compliance,iso standards

Additional Skills & Qualifications

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: • 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. • Must have excellent attention to detail and good investigation, problem solving, and organizational skills. • This position requires a 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. • Administrative experience in organizing and maintaining supplier and audit related records. • Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner. • Keeps Management informed of status of assigned projects. Knowledge/Skills: • Strong written and oral communication skills. • Excellent attention to detail and organizational skills. • Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions. • Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization. • Ability to contribute to the development of company objectives and key performance indicators. • Strong user of Microsoft Office applications.

Experience Level

Intermediate Level

Job Type & Location

This is a Contract position based out of Alameda, CA.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • 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.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.