Kelly Services is currently seeking a Laboratory Analyst (Chemical lab) for one of our top clients in Gurabo, PR
- 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 EMPOWER3.
- 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
- 2-3 year 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
- 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*
These positions have additional benefits that will be described when contacted
* Must comply with minimum established requirements to qualify
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.