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Position Summary:The Quality Specialist III performs activities of moderate variety and complexity to ensure quality and compliance with applicable regulatory requirements, including document review, audits, inspections, consulting on quality and compliance issues, training, and trend analysis.Key Job Responsibilities:Typical responsibilities of Quality Specialist III may include, but are not limited to, the following:
Performs quality review and approval of documents, data, protocols, and/or reports.
Performs quality audits and/or inspections, preparing and distributing audit reports to study director, principal investigator, and/or management in a timely manner.
Reviews laboratory deviations and investigations.
Maintains accurate quality assurance files, records, and databases, and may perform analysis and trending.
Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed.
Provide training in routine and moderately complex quality and compliance topics.
Assists with development/writing of quality SOPs, documents and/or reports as needed.
Serve as client quality liaison and/or quality host of client audits; coordinates responses to client audits.
Serve as a mentor to less experienced associates.
QualificationsEducation and Experience:
High School Diploma required, Bachelor’s degree preferred.
5 years of relevant QA experience.
Experience auditing Ligand Binding Assays (LBA), in a regulated setting that follows Good Laboratory Practices (GLP).
Detailed knowledge of and familiarity with bioanalytical laboratory procedures, processes, and common issues.
Extensive understanding of bioanalytical governmental regulations.
Familiarity with quality assurance best practices and emerging trends.
Competencies, Skills & Personal Attributes:
Excellent written and verbal communication skills.
Good basic math skills.
Good computer skills.
Strong analytical skills and attention to detail.
Strong interpersonal and customer relations skills
Ability and willingness to mentor others.
Perform all aspects of job in a way that supports company brand and supports company mission, vision and values.
PHYSICAL REQUIREMENTS
Ability to lift 20 pounds.
Ability to sit or stand for extended periods of time.
Ability to convey complex information clearly and concisely.
Ability to ascend and descend stairs.
Why Kelly ® ?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.About Kelly ®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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
