QA Associate - Core

SUMMARY/JOB PURPOSE:

The QA Core Associate supports QA Partner in GxP supplier quality management activities, vendor qualification, audit preparation, audit closure, audit observation tracking, vendor retirement, metrics collection, and records management. The position ensures data inputs in the Veeva supplier quality and audit modules and ensure audit logistics in regulatory and partner inspections.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

As QA Core associate, supports QA Partner in:

• Responsible for inputting and maintaining supplier quality and audit-related records throughout the program lifecycle.
• Responsible for obtaining and compiling data relevant to vendor risk assessments.
• Responsible for working independently and cross-functionally in authoring and updating vendor risk assessments that support the supplier quality management program.
• Support Inspection Management activities, including logistics, record management, and inspection readiness activities.
• Maintains and develops reports, templates, SOPs, procedures, and tools, based on regulatory requirements and procedures.
• Meets with internal stakeholders on audit and inspection readiness program.
• Maintains audit and inspection information in the eQMS and supplier quality record repository.
• Support internal and external stakeholders for monitoring vendor performance.
• Help compile and monitor quality metrics related to the supplier quality management and audit programs.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor’s degree preferably in the life sciences or STEM disciplines and a minimum of one year of related experience
• Equivalent combination of education and experience.

Experience/The Ideal Candidate will have:

• Minimum of 1-3 years of experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
• Must have attention to detail and good investigation, problem solving, and organizational skills.
• Administrative experience in organizing and maintaining vendor and audit related records.
• This position requires 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.
• Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
• Keeps Management informed of the 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 utilize 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.

WORKING CONDITIONS:

Facilities/Alameda:

• On-site position
• Environment: primarily working in an office setting
• Essential physical requirements: sitting, standing, and typing.
• Physical effort/lifting; light - up to 20 pounds

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