Specialist, Quality Control

Merck KGaA Darmstadt Germany • West Point, PA

113d • $85,600 - $134,800 • Onsite

About The Position

Responsible for providing quality support to a team of Laboratory Managers, Data Analysts and Laboratory Technicians. This individual is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures. The position will be responsible for support of assays performed in the Microbiology Laboratories. The candidate will lead key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility. The candidate will ensure planning and execution of continuous improvement initiatives in the Microbiology Laboratory utilizing 5S events, Kaizen events, and process mapping for culture media and reagents. This is a second shift position.

Requirements

• Bachelor's degree with required experience or preferred Master's degree or higher in microbiology, life science, scientific discipline or engineering.
• Minimum of 2 to 5 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function.

Nice To Haves

• Experience in pharmaceutical operations, lab or related environment.
• Working knowledge of general aseptic technique.
• Ability to interpret/write complex business and technical documents.
• Demonstrated interpersonal skills including flexibility, collaboration, and inclusion.
• Proven analytical aptitude and critical thinking skills.
• Strong written and verbal communication skills.
• Proven ability to manage multiple projects/tasks simultaneously.

Responsibilities

• Provide quality support to Laboratory Managers, Data Analysts, and Laboratory Technicians.
• Ensure compliance in the laboratory according to cGMPs, GLPs, and international regulations.
• Support assays performed in the Microbiology Laboratories.
• Lead key projects for Laboratory Operations to elevate compliance, assay robustness, and performance.
• Plan and execute continuous improvement initiatives in the Microbiology Laboratory.

Benefits

• Medical, dental, vision healthcare and other insurance benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree