QA Lot Disposition Specialist

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Job description

QA Lot Disposition Specialist

Tustin, CA

Direct Hire

Job Description:

The Quality Assurance Specialist is responsible for solving a variety of issues following cGMP regulations and company standards. This is a full-time direct-hire role located in Tustin, CA with a schedule of Mon-Fri 8 AM - 5 PM.

Essential Responsibilities:

• Coordinate the release of API batches and lots.
• Release of Manufacturing Buffers and Formulations.
• Assist with discrepancy investigations.
• Review of Manufacturing Batch Production Records - Must have at least 2 years or more experience.
• Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
• Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Review of testing documentation from Microbiology and Chemistry groups.
• Compilation and QA Review of all records in Batch history records.
• Issue, verify and file documents relating to processes, equipment, facilities and utilities in the manufacture of products.

Qualifications:

• B.A. or B.S. degree (preferably in Life Science).
• Minimum of 2 - 4 years of experience (4 - 6 years for Sr. level) in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation and review.
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Skillful in problem solving and analytical thinking.
• Flexibility in work hours to meet business objectives
• Audit skill and/or certification is preferred.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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