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1+ months

Specialist Manufacturing

Kelly Services
Juncos, PR 00777
**Specialist Manufacturing**


Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. Provide troubleshooting support. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. Non-Conformance and CAPA. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Assist with generation of process validation protocols and reports. Assist with the execution of the process validation. Support collection and analysis of process validation data. May participate in regulatory inspections, New Product Introductions Process or Equipment Modifications. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Assist manufacturing change owner on CCRB packages impacting the process. Projects and Initiatives Participate on the assessment or implementation of special projects or initiatives.


Requirements:

Doctorate degree OR Masters degree and 3 years of Manufacturing Operations experience or Bachelors degree and 5 years of Manufacturing Operations experience. *Detailed technical understanding of bioprocessing unit operations. Skilled in performance of GMP production operations Regulatory knowledge and interactions Participate and help lead cross-functional teams Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-07-01 Expires: 2022-09-01

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Specialist Manufacturing

Kelly Services
Juncos, PR 00777

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