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9 days old

QC Quality Auditor -pharmaceutical industry

Kelly Services
Madison, WI 53786
Manufacturing Quality Specialist


Direct Hire: Day Shift


Pharmaceutical Manufacturing Quality Specialist I


Fulltime position responsible for driving results in a fast-paced environment by supporting quality and compliant culture in manufacturing while ensuring execution against applicable regulatory requirement. These activities may include authoring and reviewing documents, conducting basic floor audits, inspections and maintaining manufacturing databases and supporting real-time documentation and impact assessment support. The position assists with the development and revision of SOPs or other quality documents as needed.


Essential Functions


Supports real-time record review, corrections, and provides feedback to the manufacturing team to drive right-first-time documentation and execution.


Performs quality investigations, review and approval of draft and executed documents, data, basic protocols, and/or reports.


Performs basic quality floor audits and/or floor inspections to proactively reduce or eliminate errors that could result in quality investigations.


Supports manufacturing leadership in quality impact assessments.


Maintains and ensures accuracy of manufacturing databases such as, investigation tracker, master batch record tracker, etc.


Utilizes knowledge gained through investigations, floor audits and inspections to identify and drive quality improvement initiatives as needed.


Provides assistance, guidance, and training to operators on all areas of cGMP and compliance as needed. Has the ability to provide input and suggestions on existing procedures or help create new ones. Maintains accurate files and records.


Complies with company policies and SOPs.


An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Utilizes proper PPE when necessary in performing job function. Key Competencies } Knowledge of regulations and SOPs applicable to area of responsibility.


Good written, oral communication and math skills. Ability to interact well with employees at all levels.


Bachelor s degree in Chemistry, Biology, or related field with 2+ years GMP related experience, or equivalent educational and work experience.


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-13 Expires: 2021-11-22

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QC Quality Auditor -pharmaceutical industry

Kelly Services
Madison, WI 53786

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