This hiring is directly by the company for a period of 12 months. **Job/Position Description** Analyze and ensure that the materials/products analyzed meet quality specifications and are within specification and trend. Review that imported batches comply with their difference compared to the supplier's certificate for line batches. Optimize the operation of activities carried out within the quality laboratory. Perform analyses of raw materials, finished products, processes, validations, stability samples, transfers, and implementation of new analytical methods. Maintain your safety and that of others through the use of personal protective equipment and shared responsibility for safety in the area. Comply with Good Laboratory Practices and Documentation Practices in all analyses performed. **Responsibilities** * Ensure compliance with Good Laboratory Practice systems. * Meet committed deadlines for analyzed materials. * Meet established deadlines for stability study analyses and reports, as well as review (right first time). * Ensure proper use and handling of laboratory equipment. * Always adhere to laboratory procedures and techniques. * Comply with established safety and hygiene practices. * Participate in audits conducted to the department. * Monitor adherence to and compliance with corporate policies. * Fulfill the training and qualification program. * Meet site-established metrics. * Implement improvements in the Chemical Control laboratory based on IPS principles and the 8 steps of Problem Solving. * Monitor the implementation of policies and guidelines applicable to the area. * Comply with proper usage and timely data upload for routine analyses in ORGLIMS and for stability samples in the NOVALIMS system. * Comply with proper usage of the Empower Chromatography System during analysis and calculation of chromatographic results. * Ensure data integrity in analytical systems used in the laboratory, as well as tests performed following ALCOA principles. **Education, Experience and Required Skills** * Degree in: Chemistry and Pharmaceutical Biology, Industrial Pharmacy, or related field in Chemistry or Pharmaceutical Sciences * Experience: In raw material and finished product analysis, minimum 1 year. * Knowledge of good laboratory practices, handling of pharmacopoeial compendia. * Microsoft Office. * Language: Basic English. * Focus on results and customer orientation. * Win-win attitude. * Independent. * Openness and adaptability to change. * Action-oriented. * Fast learner and problem-solving focused. * Good relationship with peers. * High degree of integrity and trust. * Proactive. * Ensure implementation of continuous improvement projects. * Effective participation. * Teamwork. * Handle pharmacopoeial compendia (USP, FEUM, BP, JP). * Operate laboratory equipment such as balances, spectrophotometer, IR, pH, HPLC, GC (optional), Atomic Absorption (optional), nitrogen determination (optional). **Education, Experience and Desired Skills** * Comply with NOM-059-SSA1 Good Manufacturing Practices for Medicines and applicable health regulations. * Comply with applicable Quality Policies and Company policies. * Support the Quality Department in all audit processes (SLT/Managers). * Comply with the Company's Safety, Health and Environment standards and applicable regulations in Mexico, ensuring compliance. * Agree and fully comply with the approved training program with immediate supervisor according to regulatory and company requirements. * Work within an inclusion culture as an effective means to achieve an effective and productive work environment. **Secondary Job Description** **Who We Are:** Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. **Search Firm Representatives Please Read Carefully** Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Annualized Salary Range** **Annualized Salary Range (Global)** **Annualized Salary Range (Canada)** **Please Note: Pay ranges are specific to local market and therefore vary from country to country.** **Employee Status:** Temporary (Fixed Term)**Relocation:** Domestic**VISA Sponsorship:** **Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites** **Flexible Work Arrangements:** **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Number of Openings:** 1 **Requisition ID:**R536963