30 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.


' BS Degree in Science, Pharmacy and/or Engineering Five (5) years of experience in a Parenteral Manufacturing facility. Knowledge of computers applications (Microsoft Word, Excel, Power Point) Excellent communications skills in Spanish /English Provides operational, scientific expertise and compliance knowledge support to the Manufacturing Sterile Operations.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**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 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.


Posted: 2021-05-21 Expires: 2021-06-21

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Operations Process Support Specialist

Kelly Services
Manatí, PR 00674

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