QC Tissue Analyst II
: Job Details :

One of our large pharmaceutical clients is looking to bring on a QC Tissue Analyst II to join their growing Tissue Culture Lab team in Malvern, PA. This Analyst will be responsible for conducting cell-based assays of in process samples submitted to the QC laboratory and documenting all QC investigations. 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, organizational leadership, interpersonal skills, a quality mindset, critical thinking, and technical writing skills. This position will be the shift leader and primarily work independently. Key Responsibilities:

• 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 biochemical, microbiological, and/or general chemical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Maintain Laboratory Housekeeping including: sample management, reagent prep, instrument standardization/calibration
• Maintain individual training completion in a compliant state and train new laboratory personnel
• Participate in continuous improvement and complete document revisions
• Execute CAPAs when required for the Quality Control organization
• Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections
• Provide input to functional laboratory meetings

Qualifications:

• Bachelor's Degree in a scientific field of study
• Minimum of 2 years of ELISA experience
• Prior GMP work experience

Pay Range: $75,000 - $85,000 (flexible based on years of experience)

Hours: Monday-Friday, 8:00am-4:30pm

PTO: 10 PTO days & 6 paid sick days annually

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

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.