The Senior Quality Control Analyst- Microbiology will support quality control testing operations. The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to complete assigned work.
Essential Functions and Responsibilities:
Perform daily cGMP quality control laboratory microbiological testing activities.
Perform environmental monitoring of the cleanroom areas as scheduled.
Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
Perform all activities for cGMP compliance.
Support thorough cGMP investigations for out-of-specification test results.
Support technical problem-solving.
Support product stability programs, including execution of stability testing, stability data analysis, and final reporting of stability data.
Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls
Perform peer review of laboratory data and logbooks.
Provide input to functional laboratory and cross functional team meetings.
Act as subject matter expert (SME) on one or more assays and train new laboratory personnel.
Solid understanding and functional knowledge with hands on experience with the following: environmental monitoring, endotoxins, sterility, growth promotion, and mycoplasma.
Proficient in performing technical writing (e.g., test methods, SOPs, protocols, deviations, CAPAs, change controls, etc.)
Extremely detail oriented
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Support inspections as needed.
Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
Work in a cleanroom with biohazards, human blood components, and chemicals
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge:
Bachelor's degree in a relevant discipline (biological sciences or equivalent)
Minimum five (5) years of experience in the pharmaceutical industry within a Quality Control role
Successfully interface with multi-disciplined teams
Extremely detail-oriented with strong technical skills
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
High level of ownership and accountability
Demonstrate a sense of urgency; ability to recognize time sensitivity.
Previous experience with GDP, GLP, GMP Preferred Education, Skills, and Knowledge
Advanced degree (MSc. preferred.)
Experience with cell therapy products is a plus.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
Must be able to work in a cleanroom lab setting with biohazards / various chemicals.
Must meet requirements for and be able to wear a half-face respirator.
Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to lift and carry objects weighing up to 45 pounds.
Mental:
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors.