Specialist, Quality Control (Temporary)

Description

Job Summary: A professional who ensures compliance with Good Laboratory Practices (GLP), proper use of equipment, and continuous improvement in Chemical Control. Key Highlights: 1. Ensure compliance with Good Laboratory Practices (GLP) and regulations. 2. Implement improvements and ensure data integrity in analytical systems. 3. Manage and maintain quality control equipment and instruments. Job Description **Temporary Position: 3 Months** ================================== **Location:** **Xochimilco** ============================= **Key Responsibilities** ================================= * Ensure compliance with Good Laboratory Practice (GLP) systems. * Meet committed deadlines for analyzed materials. * Meet established deadlines for stability study analyses and reports, as well as first-time review. * Ensure proper use and handling of laboratory equipment. * Always adhere to laboratory procedures and techniques. * Comply with established safety and hygiene best practices. * Participate in audits conducted on the department. * Monitor adherence to and compliance with corporate policies. * Complete the required training and qualification program. * Meet site-established metrics. * Implement improvements in the Chemical Control laboratory based on MPS principles. * Monitor implementation of applicable policies and guidelines for the area. * Ensure proper and timely downloading of data generated for routine analyses in GLIMS and for stability samples in the NOVALIMS system. * Ensure proper use of the Empower Chromatographic System during chromatographic analyses and result calculations. * Ensure data integrity in analytical systems used in the laboratory, as well as tests performed following ALCOA principles. * Ensure that Quality Control equipment and instruments comply with all regulatory requirements for GLP/GMP and align with corporate policies and guidelines, such as Standard Operating Procedures (SOPs) for equipment, qualification, calibration, and maintenance of laboratory systems. * Maintain and calibrate assigned equipment and instruments at optimal levels, with required frequency, ensuring compliance with regulatory requirements, data integrity, and proper functionality. * Support preparation of expenditure and capital budgets related to equipment and their spare parts and supplies within authorized limits. * Manage necessary activities to identify and resolve issues related to Equipment, Instruments, and Systems in Chemical Control Laboratories, emphasizing prompt and definitive resolution to minimize impact and recurrence. * Ensure control status of Quality Control Laboratory systems through implementation of operating procedures, preventive maintenance programs, calibration programs, calibration alert notifications (OOT), and change control. * Review reports or service records provided by external vendors or other departments for Equipment, Instruments, and/or Quality Control Systems. Follow up on Out-of-Tolerance (OOT) results arising from calibrations. * Track timely closure of Deviations, CAPAs, Change Controls, and Audit Action Plans related to equipment. * Close work orders. * Deliver assigned activity results within the established timeframe. * Execute necessary activities to comply with recommendations from quality, safety, hygiene, and ecology audits. * Generate Purchase Orders in the established SAP system when required. **Profile** ========== Degree in: BSc in Pharmacy, BSc in Food Chemistry, or a related field in Chemistry or Pharmaceutical Sciences. Experience: Minimum 1 year in raw material and finished product analysis. Knowledge: Good Laboratory Practices (GLP), handling of pharmacopoeial compendia. Microsoft Office. Language: Basic English. **Competencies / Required Skills:** ========================================== * Focus on results and customers. * Win-win attitude. * Independent. * Openness and ability to adapt to change. * Action-oriented. * Quick learner focused on problem solving. * Good relationship with peers. * High degree of integrity and trustworthiness. * Proactive. * Ensure implementation of continuous improvement projects. * Effective participation. * Handle pharmacopoeial compendia (USP, FEUM, BP, JP). * Operate laboratory equipment: balances, spectrophotometers, IR, pH meters, HPLC. **Required Skills:** Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Commercial Analytics, Commission Analysis, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Marketing Analysis, Microbiological Analysis, Microbiological Test, Pharmaceutical Quality Control (QC), Product Analysis, Product Management, Product Profitability Analysis, Product Research, QC Microbiology, Quality Control (QC), Retail Marketing, Software Quality Control, Teamwork {\+ 2 more}**Preferred Skills:** Current Employees apply HERE Current Contingent Workers apply HERE **Search Firm Representatives Please Read Carefully** Merck \& Co., Inc., Rahway, NJ, USA, also known as Merck Sharp \& Dohme LLC, Rahway, NJ, USA, 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. **Employee Status:** Temporary (Fixed Term)**Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Not Applicable**Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 05/16/2026* **A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:**R393816