




* Although one or more potential candidates have been identified for this position through internal succession planning, we will consider applications from any interested candidate. **Job/Position Description:** The Associate Specialist, Quality Control role involves performing routine physicochemical testing of finished product batches, ensuring they meet corporate and regulatory requirements. Additionally, it includes conducting second-person reviews of routine laboratory analyses and tests, including review of electronic records to ensure data integrity. As an Associate Specialist, Quality Control, you will write and update procedures, protocols, and reports; participate in analytical method transfers; and conduct laboratory investigations, initiate change controls, deviations, and CAPAs. This role is essential in supporting the maintenance of quality, accuracy, and reliability standards for results, contributing to the safety and efficacy of the company’s products. **Responsibilities:** * Perform routine physicochemical quality control tests on finished products by preparing solutions and reagents (mobile phases, diluents, samples, and standards, etc.) to ensure compliance with applicable specifications. Complete all relevant documentation, including but not limited to analytical results, calibration records, equipment usage logs, to ensure compliance with Organon Argentina’s procedures. * Write and review documentation related to standard operating procedures (SOPs), work sheets, and certificates of analysis (CoAs). * Carry out all activities in accordance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to ensure compliance with regulatory requirements. **Education, Experience and Required Skills:** * Hold a Chemical Technician diploma or be currently enrolled in a technical or university program related to the pharmaceutical industry. * Minimum of 1 year of experience in the pharmaceutical industry or related industries in similar roles. * Proficiency in the use of laboratory analytical instrumentation, including but not limited to: HPLC, EMPOWER software, UV\-Vis, and dissolution testers. * Proficiency in computer systems, including general Microsoft Office suite (Excel, Word, Outlook, etc.). * Solid understanding of current Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and pharmacopoeial methods. **Desired Education, Experience and Skills:** * Planning and organizational skills. * Strong written, oral, and interpersonal communication skills. * English language proficiency: reading/writing/speaking: intermediate level. **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:** Regular**Relocation:** No relocation**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:**R536827


