Job title: QA Associate/Auditor (Direct Hire)
Job description: *Quality Assurance Analysts/Auditor – NW of Houston, TX (Direct Hire)* *Sign-on Bonus!* Kelly Science is currently recruiting candidates for several Quality Assurance Analyst/Auditor positions at a biopharma company NW of Houston TX. The Quality Assurance Analyst will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. *Job Responsibilities:* * Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to: * Standard Operating Procedures * Batch Production Records (completed and approval) * Commissioning, qualification and validation protocols and reports * Deviation Reports * Corrective Action/Preventive Action Plans * Technical / QC data review and approval * Drug Substance/Product Reports * Trending QA data * Draft and review internal Quality policies, procedures and reports. * Perform inspection of final product containers and review and/or approval of executed process records and data. * Perform Quality audit functions to include, but not limited to: * Audit of lab notebooks * Audit of equipment logbooks * Review of vendor, supplier, contract laboratory audit questionnaires * Lead vendor, supplier, contract laboratory and client audits * Identify process and Quality System improvement opportunities. * Provide daily guidance for the compliance of the QA department to national and international standards and regulations. * Support Regulatory, client, and internal audits. * Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups. * Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. * Assist with compliance related functions. *Job Requirements:* There are multiple levels of positions available for varying levels of education, BS and MS, and years of Quality Assurance experience supporting pharmaceutical, biopharmaceutical or biotechnology products. Some exposure to good documentation practices, cGMP/GLP regulations is required. These are direct hire positions with compensation commensurate upon level of education and applicable experience. If you meet the above qualifications, please submit your resume for immediate consideration. 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/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](https://www.mykelly.us/us-mykelly/perks/)?). 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.](https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) ]]
Location: Dallas, TX
Job date: Sun, 02 May 2021 07:45:26 GMT
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