Quality Associate II (3457)
The Quality Control Analyst II in Microbiology is responsible for microbiological analysis of in-process, release and stability samples to support the manufacturing of biologic drug substances. In addition, the Quality Control Analyst II is responsible for performing environmental monitoring of clean rooms and water system sampling/testing.
Position schedule is 1st Shift, Monday-Friday, 8:
00am - 4:
30pm, and also requires participation in the Quality Control team's weekend coverage rotation. Weekend differentials apply. .
o In accordance with test method SOP's, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, Media performance, Growth promotion and Microbial identifications. o Perform environmental monitoring of cleanrooms and water system sampling. o Investigate, assess, and troubleshoot assay and/or equipment problems. o Notify QC Supervisor immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered. Initiate and participate in authoring investigation report. o Participate in method qualifications, validations, and transfers. o Maintain sample tracking and integrity at all times until analyses are reviewed.
o Provide guidance to junior analysts and communication to management. o Ensure analytical equipment is calibrated and well maintained at all times. o Perform general lab maintenance. Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations. o May prepare and complete change control requests using electronic systems such as Trackwise. o Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed.
o Maintain data integrity and ensure compliance with relevant regulations such as SOPs, FDA, CGMP, Eu. Ph.,GLP, GDP, and QSR o Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. o Support principles such as 5S throughout daily work activities. o Ensure personal training requirements are met and that training records are current.
o Knowledge and control of analytical equipment including determining when and what kind of maintenance is needed. o Knowledge of computer software, including relevant applications such as Microsoft Office and LIMS.
o Knowledge of CGMPs regulations including GMP practices for method transfer, qualification and validation.
o Demonstrated understanding of quality systems including change control, deviations and CAPAs.
o Demonstrated knowledge of aseptic technique and impact of product and facility contamination.
This includes the performance of microbial identifications and relevant investigations to understand the source of contamination and means to minimize or prevent further occurrence. o Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
o Strong written and verbal language skills to effectively read and write SOP's and related lab reports and communicate with personnel at all levels in the organization.
o Bachelor's degree in Microbiology, Biology or a related scientific discipline.
o Minimum 3- 5 years' experience in pharmaceutical or biotech Quality Control in a GMP environment with specific experience in microbiological testing and sampling. o Regular attendance is necessary to perform the essential functions of the job. o Weekend, holiday and modified shift coverage required to complete related activities. o Light work, frequent lifting up to 10 lbs; frequent standing/walking.
o Laboratory environment working with chemical reagents and analytical equipment o Entry into utilities rooms for water sampling o Clean Room gowning and scrubs o Personal Protective Equipment o Normal office working conditions:
computer, phone, files, fax, copier. o Minimum travel required (Less than 10% domestic).Estimated Salary: $20 to $28 per hour based on qualifications.
Position schedule is 1st Shift, Monday-Friday, 8:
00am - 4:
30pm, and also requires participation in the Quality Control team's weekend coverage rotation. Weekend differentials apply. .
o In accordance with test method SOP's, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, Media performance, Growth promotion and Microbial identifications. o Perform environmental monitoring of cleanrooms and water system sampling. o Investigate, assess, and troubleshoot assay and/or equipment problems. o Notify QC Supervisor immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered. Initiate and participate in authoring investigation report. o Participate in method qualifications, validations, and transfers. o Maintain sample tracking and integrity at all times until analyses are reviewed.
o Provide guidance to junior analysts and communication to management. o Ensure analytical equipment is calibrated and well maintained at all times. o Perform general lab maintenance. Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations. o May prepare and complete change control requests using electronic systems such as Trackwise. o Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed.
o Maintain data integrity and ensure compliance with relevant regulations such as SOPs, FDA, CGMP, Eu. Ph.,GLP, GDP, and QSR o Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. o Support principles such as 5S throughout daily work activities. o Ensure personal training requirements are met and that training records are current.
o Knowledge and control of analytical equipment including determining when and what kind of maintenance is needed. o Knowledge of computer software, including relevant applications such as Microsoft Office and LIMS.
o Knowledge of CGMPs regulations including GMP practices for method transfer, qualification and validation.
o Demonstrated understanding of quality systems including change control, deviations and CAPAs.
o Demonstrated knowledge of aseptic technique and impact of product and facility contamination.
This includes the performance of microbial identifications and relevant investigations to understand the source of contamination and means to minimize or prevent further occurrence. o Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
o Strong written and verbal language skills to effectively read and write SOP's and related lab reports and communicate with personnel at all levels in the organization.
o Bachelor's degree in Microbiology, Biology or a related scientific discipline.
o Minimum 3- 5 years' experience in pharmaceutical or biotech Quality Control in a GMP environment with specific experience in microbiological testing and sampling. o Regular attendance is necessary to perform the essential functions of the job. o Weekend, holiday and modified shift coverage required to complete related activities. o Light work, frequent lifting up to 10 lbs; frequent standing/walking.
o Laboratory environment working with chemical reagents and analytical equipment o Entry into utilities rooms for water sampling o Clean Room gowning and scrubs o Personal Protective Equipment o Normal office working conditions:
computer, phone, files, fax, copier. o Minimum travel required (Less than 10% domestic).Estimated Salary: $20 to $28 per hour based on qualifications.
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