- Performs the following laboratory analysis and activities in accordance with cGMP’s practices, internal and external regulations and company policies: Characterization, Confirmation, Registration, and Validation activities, Bulk Holding studies, Stability studies, and Comparability studies.
- Ability to understand and apply SOPs and use cGMPs for document and maintains an accurate laboratory documentation, including sample data for all tests performed utilizing the following programs: LIMS, and EMPOWER.
- Proper and timely documentation in instrument logbooks in accordance with current company SOPs.
- Understand and follow all company’s Safety Procedures.
- Complies with the established deadlines, with the overall business and process goals for Drug Substance and Drug Product testing protocols (Characterization, Confirmation, Registration, and Validation activities, Bulk Holding studies, Stability studies, and Comparability studies).
- Documents all practices as well as the appropriate technical details of work performed, in laboratory documents, forms, requests and reports in compliance with cGMP document standards.
- Completes documentation of data generated in a timely manner and according to product specifications and/or protocol specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release or data approval of lot for any laboratory investigation required.
- Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible/IR spectrophotometers, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC, UPLC and HPLC chromatographers, dissolution baths and any other computerized system.
- Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated.
- Trends results against historical data (product data and batch data).
- Identifies and communicates atypical results, out of trend results and out of specification results to management and recommends corrective actions.
- Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions.
- Assures all containers and glassware used are properly labeled during usage at all times.
- Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety.
- Daily communication with team members concerning testing, project plans and results.
- Collaborates and communicates with analytical colleagues, and partners with cross functional peer groups and management, in planning and execution of projects within timelines.
- Calibrates or verifies the equipment in accordance with manufacturer or SOP requirements.
- Enters and facilitates work orders to repair equipment as needed.
- Assists in training of new analysts as directed.
- Supports stability sampling coordination, stability sample shipping and completion of documentation required in the eLims system.
- B.S. in Chemistry
- At least 2 year of experience in GMP Analytical Lab
- Computer literacy: MS Word, Excel and PowerPoint.
- Multi-project experience and the ability to collaborate and communicate effectively.
- Knowledge of cGMP’s and compliance
- Technical knowledge of Chemistry
- Broader knowledge of basic sample preparation techniques
- Computer and Software skills; LIMS system basic knowledge
- Bilingual (English & Spanish)
- Technical writing skills
- Problem solving/troubleshooting
- Good Communication skills: writing, listening and speaking
- Problem Solving & Troubleshooting
- Available 1st, 2nd and 3rd shift ( some positions will be for 3rd shift after trainings completed, Salary have Shift differentials)
Kelly PR Offer:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay
- *Four holidays paid by year and Christmas bonus*
* Must comply with minimum established requirements to qualify
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 interests—it’s 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.
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. 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.]]
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.
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