JobWatch

22 days old

Operations Process Support Specialist

Kelly Services
Manatí, PR 00674
**Operations Process Support Specialist**


Responsible for executing manufacturing investigations (QEs), Corrective Action Preventive Action (CAPAs),NTRs, NOEs, procedures development & revision, and process validation documentation. Acts as facilitator for the necessary information related to the support of the existing processes, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation. Ensures that all QEs, NTRs, NOEs and CAPAs are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence. Reviews and provides input to regulatory submissions applicable to area of responsibility. Leads QEs and CAPAs trend evaluation. Participates in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications. Supports establishment of process monitoring parameters and control limits. Supports the assessment of deviations and process monitoring data. Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality. Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMPs compliance. Write, evaluate and revise the required manufacturing documentation (i.e. SOPs, MBRs, etc.) and may assist in providing training on scientific or technical aspects of the processes. Assists with generation and execution of validation protocols and reports.


Requirements:


BS Degree in Science, Pharmacy and/or Engineering


Three (3) years of experience in a Regulated Environment.


Strong technical writing and presentation skills


**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)

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Posted: 2022-06-06 Expires: 2022-07-07

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Operations Process Support Specialist

Kelly Services
Manatí, PR 00674

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