Quality Specialist

Job Description

Qualifications:

Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the pharmaceutical industry. Preferred Experience and Skills: Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role. Previous experience in food or pharmaceutical environment in regulatory/inspection role. Previous experience in project management, process data analysis. Lean Six Sigma Certification Previous Experience with SAP,MEDS, etc. Additional: Beta Lactam screening required for this role. Shift Requirements: 8am-5pm. The successful candidate will support aseptic operations.

Responsibilities:

The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations. The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation. The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning. May perform quarantine functions and accountability reviews. Supports special projects as assigned. The role follows cGMP and routinely makes decisions using cGMP/process knowledge. May work with customers to resolve problems and to satisfy quality and production needs. Follows site safety requirements. Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols. Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams. The individual tracks/reports metrics as needed. May provide training/ presentations as needed. May help with regulatory inspections.Company Description

Merck Sharp & Dohme Corp. ("Merck") is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures, and markets a broad range of innovative products to improve human health, directly and through its joint ventures

Imagine getting up in the morning for a job as important as saving and improving lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery or scientific genius to work in collaboration with other like-minded colleagues to pursue and bring hope to countless people who are battling the most challenging diseases of our time. Our team is always evolving, so if you are among the intellectually curious, join us—and start making your impact today.