We are seeking two highly motivated, proactive professionals for a hybrid Technical Operations / Quality Assurance position within Merck Research Laboratories (MRL) based in West Point, PA. This role is primarily focused on the evaluation, review, and batch disposition of clinical finished goods and materials to ensure total conformance with company policies and regulatory standards. Operating within a collaborative and forward-thinking team, you will serve as a key partner to floor operations, utilizing lean methodologies to drive process improvements and support quality event investigations.
Responsibilities
- Evaluate and disposition clinical finished goods and supply materials, ensuring that all materials are produced in strict compliance with company procedures and governing regulations.
- Review clinical finished goods batch records, perform batch disposition activities, conduct label reviews, and support overall batch/product review tasks.
- Coordinate and support the preparation of standard procedures, manufacturing processes, and quality improvement initiatives.
- Partner closely with operations teams, actively asking questions, seeking resolutions on batch record discrepancies, and confidently challenging processes to suggest innovative advancements.
- Complete targeted projects to optimize process performance, including continuous process improvements and value capture initiatives designed to improve yield, reduce cost, or lower cycle times.
- Actively use and champion Lean Six Sigma and the Merck Production System (MPS) tools in daily operational activities and problem-solving.
- Assist in the coordination of significant quality events, providing fact-finding and direct investigation support.
Education
- Bachelor's Degree or higher in engineering, science, or a related discipline.
Experience
Required:
- Minimum of 2 years of experience in the pharmaceutical or equivalent industry within a Good Manufacturing Practice (GMP) related field (Technical, Engineering, Quality, or Operations).
- Direct familiarity with batch disposition activities.
- Strong problem-solving, organizational, time management, and written/oral communication skills.
- Proven ability to multi-task, manage multiple priorities, work independently, and collaborate effectively as part of a team.
- Proficiency in using and maintaining standard Microsoft applications (Excel, Outlook, Teams, and/or MS Access).
- High attention to detail, flexibility, and a proactive awareness of production and quality control challenges.
Preferred:
- Hands-on computer systems competency and knowledge of industry-specific platforms such as ERP, SAP, MEDS, and VEEVA.
- A proactive, outgoing, and adaptable mindset, with an openness to innovation—including AI-related process improvements.
Additional Information
- Openings Available: 2 positions.
- Work Location & Schedule: This is a hybrid role based out of West Point, PA requiring 3 days on-site per week. Tuesday and Wednesday are mandatory on-site days; the third day is flexible (typically Monday or Thursday).
- Hours: 8 hours per day / 40 hours per week (within MRL). No overtime and no travel required.
