QC Microbiological I

Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. * Perform duties in accordance with quality criteria, safety and health standards. * Carry out job responsibilities in alignment with the company's established Behavioral Values. * Work in compliance with GMP regulations. * Report completed work to the Microbiological Quality Control Supervisor / Technician. * Documentation tasks: * + Identification of potential Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, and deviations; participation in related investigations. * + Documentation of performed activities in accordance with GMP standards and LSNE\-León work procedures. * Laboratory work: * + Execution of microbiological testing and analysis according to established internal methods and procedures; interpretation of results. * + Conducting environmental and personnel monitoring in applicable areas. * + Organization and execution of garment qualification for entry into classified cleanrooms. * + Performing microbiological sampling and analysis of raw materials, bulk product, intermediate product, finished product, and packaging materials. * + Managing calibration, verification, and maintenance of analytical equipment. * + Interpretation and implementation of GMP documentation applicable to the Microbiological Quality Control laboratory. * + Sample management and control. * + Management and control of laboratory materials, reagents, reference strains, culture media, etc., used in the Microbiological Development laboratory; communication of requirements to the Technician / Supervisor. * + Organization and cleaning of laboratory rooms. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future **Equal Employment Opportunity (EEO) Statement:** *PCI Pharma Services is an Equal* *Opportunity/Affirmative* *Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.* *At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life\-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*