Senior Specialist QA Assistant

Quality Control Lab Associate Specialist

Quality Control Lab Associate Specialist performing environmental monitoring and quality control assays. Education/Experience Requirements:
Associate's degree in Biology, Microbiology, Biochemistry, or related field plus 1-2 years of relevant laboratory/pharmaceutical experience. Bachelor's degree in Biology, Microbiology, Biochemistry, or related field. Required

Experience and Skills:

Understanding and application of Good Laboratory Practices and cGMPs. Aseptic technique. Performance of environmental and water systems monitoring. Working in a team environment. Preferred

Experience and Skills:

Strong verbal and written communication skills. Experience with LIMS, SAP or other laboratory/production software systems.

Shift: 1st Shift Days - Weekends Required Shift available: (Sunday – Thursday) and (Tuesday – Saturday). The start and end time will be 8:30AM – 5PM with flexibility for early and later start times depending on EM needs. 8 hour shift with a 30 minute lunch break.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Imagine getting up in the morning for a job as important as helping to save and improve 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 a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.

Additional Responsibilities:

• General:
  Conducts release testing in support of finished product, including sterility testing, detection of residual moisture, average cell dry weight testing. Conducts microbiological testing; evaluation of environmental microbiological samples. Conducts environmental monitoring sampling to include active air and surface sampling and water sampling. Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects.
• Business & Functional Expertise:
  Completes assignments in alignment with department objectives. Conducting In-Process and Release testing. Conducting Environmental Monitoring of processes and on a routine basis. Problem Solving:
  Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head.
• Impact Influence:
  Communicates information, asks questions and checks for understanding. Accountability:
  Accountable for own performance. Decision Making:
  Makes decisions – guided by policies and procedures – on the shop floor. Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

Working Relationships:
Reports to Quality Control manager. Interacts with employees within own department and other departments.