Kelly Services Chemist, Gurabo, PR in Gurabo, Puerto Rico
LAB ANALYST - Gurabo, Puerto RIco
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.
Professional Requirements: B.S. in Chemistry. 2-3 year experience in GMP Analytical Lab
Additional Skill Requirements: 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
Ability on training colleagues on analytical techniques
Good Communication skills: writing, listening and speaking
Problem Solving & Troubleshooting
Apply now for immediate consideration!
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With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm