Senior Specialist QA - I (Assistant)

About the role

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.

Responsibilities

• 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
• Completes assignments in alignment with department objectives
• Conducting In-Process and Release testing
• Conducting Environmental Monitoring of processes and on a routine basis
• Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head
• Communicates information, asks questions and checks for understanding
• Accountable for own performance
• 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
• Reports to Quality Control manager
• Interacts with employees within own department and other departments

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

Preferred Skills

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

Schedule

• 1st Shift - Weekends required
• Shift available: (Sunday – Thursday) and (Tuesday – Saturday)
• Positions available: 2
• Start and end time: 8:30AM – 5PM with flexibility for early and later start times depending on EM needs
• 8 hour shift with a 30 minute lunch break