One of our large pharmaceutical clients is seeking to bring on a QC Analyst II to join their growing team in Malvern, PA. This position supports the Quality Control Microbiology laboratories and conducts microbiological testing of raw materials, utilities, in-process or final product samples submitted to the QC laboratories. The position requires analytical testing to be completed in compliance with all applicable procedures, standards and GMP regulations. This position requires high attention to detail, good aseptic technique, organizational leadership, interpersonal skills, a quality mindset, critical thinking, and technical writing skills. This position will work in a team environment and support 2nd shift which is Tuesday-Saturday, 2:00pm-10:00pm. Other responsibilities include:

• Perform analytical testing in compliance with applicable GMP regulations while maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations.
• Conduct microbiological testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Perform peer review of laboratory data and participate in continuous improvement
• Perform Bioburden, Endotoxin, Microbiological Plate Reading, Growth Promotion and Microbial Identification Testing
• Utilize electronic systems - LIMS, Trackwise, MES, SAP, etc. for execution and documentation of testing
• Maintain Laboratory Housekeeping including: sample management, reagent prep, instrument standardization/calibration, maintaining laboratory inventory
• Maintain individual training completion in a compliant state and train new laboratory personnel
• Execute CAPAs when required for the Quality Control organization
• Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections

Requirements:

• Bachelor's Degree in a Science related field
• Minimum of 1 year of prior GMP work experience
• Prior QC or Microbiology related laboratory experience

Salary: $70,000-$80,000 (can be flexible based off experience)

Schedule: Tuesday-Saturday, 2:00pm-10:00pm

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO: 10 days annually & 6 sick days

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.