Responsible for executing manufacturing investigations (QE’s), Corrective Action Preventive Action (CAPA’s),NTR’s, NOE’s, 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 QE’s, NTR’s, NOE’s and CAPA’s 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 QE’s and CAPA’s 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 cGMP’s compliance. Write, evaluate and revise the required manufacturing documentation (i.e. SOP’s, MBR’s, 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.
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, we’re here every step of the way to find your dream engineering job.
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?). 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.]]
Why Kelly - Since 2011 we have placed over 16,000 Veterans
Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience. The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition. Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility. Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers. Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.
Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.
Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States. Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards. In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel. These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.
Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.
A People Company, Staffing the World
Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.