Quality Control Analyst

Description

Position Summary: We are seeking a Quality Control Analyst for the Laboratory Operations area, focused on Sterility and Microbiology, to perform and review assays in accordance with quality standards and GMP. Key Highlights: 1. Key role in microbiological control and product release 2. Participation in laboratory investigations and incident handling 3. Contribution to quality under Good Manufacturing Practices (GMP) Job Description **Quality Control Analyst** **Job Description** At **our Salamanca facility**, we are looking to hire a **Quality Control Analyst** for the **Laboratory Operations** area, with a focus on **Sterility and Microbiology** activities. This position is onsite and includes a **working schedule of 14:00–22:00**. The selected candidate will be responsible for performing, reviewing, and documenting required assays in accordance with established procedures, ensuring at all times compliance with quality standards and **Good Manufacturing Practices (GMP)**. **General Purpose of the Position** To ensure proper execution of microbiological control tasks in the laboratory, contributing to the release of intermediate products, finished products, plant services, and stability studies—always in compliance with applicable regulatory and quality requirements. **Main Responsibilities** * Perform microbiological control assays in Sterility and Microbiology areas. * Collaborate in the release of intermediate products, finished products, plant services, and stability studies in accordance with official procedures. * Conduct monitoring and recordkeeping for laboratory equipment. * Plan consumption of materials and reagents, and place orders via **SAP**. * Record results in authorized systems and forms within required timeframes. * Review assays performed by other analysts. * Participate in preliminary incident investigations and collaborate in laboratory investigations as needed. * Manage assay reference standard controls. **Requirements** * University degree or vocational qualification in Laboratory Sciences. * Prior laboratory experience in the pharmaceutical industry. * Knowledge of **SAP** (desirable). * Proficiency with Microsoft Office suite. * Knowledge of **GMPs**. * Ability to work effectively in a team. * Strong oral and written communication skills. * English language proficiency at **B2 level** (desirable). * Experience in microbiological control assays. **Desired Competencies** * Effective communication * Quality control * GMP compliance * Document management * Laboratory investigations and OOS * GMP laboratory * Laboratory analytical techniques * Materials and testing management * Technical writing * Proficiency in LIMS, SAP, and technical procedures **Required Skills:** Bioproducts, Communication, Compound Management, GMP Compliance, GMP Laboratory, Keen Observation, Laboratory Analytical Techniques, Laboratory Informatics, Laboratory Information Management System (LIMS), Laboratory Investigations, Laboratory Operations, Laboratory Services, Metagenomics, Microbiological Cultures, Microbiological Test, Microbiology, OOS Investigations, Oral Communications, Quality Standards, Recordkeeping, Standard Operating Procedure (SOP) Writing, Sterility Testing, Technical Procedures, Technical Writing, Test Procedure Development**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:** Regular**Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Not Applicable**Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 06/25/2026* **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:**R402212