Proclinical is advertising an attractive new job opportunity with a leading multinational pharmaceutical company seeking a QC Analyst I - Microbiology with a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit the QC Analyst to their office in Minnesota.
Job Responsibilities:
- Performing supportive activities for general lab readiness, laboratory equipment qualification, and method transfers.
- Conducting critical biological test methods, including samples generated for in-process, drug substance, and stability.
- Using a variety of laboratory instrumentation and computer systems to collect and record data, such as LIMS.
- Following SOPS to perform methods requiring precise analytical skills and understanding of biology and chemistry principles.
- Completing all testing, including all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintaining data integrity and ensuring compliance with company SOPs, specifications, and cGMP regulations.
- Exercising judgment within defined Quality Control procedures and practices to determine appropriate action.
- Initiating low severity level deviations, CAPAs, and change controls within the electronic Quality Management System.
- Participating in functional efforts involving teams to solve problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
- Authoring minor revisions to existing SOPs.
- Receiving general instructions on routine work and detailed instructions on new assignments.
- Performing equipment maintenance and calibrations as required.
Skills and Requirements:
- Experience in:
- Endotoxin (Charles River/Lonza methods; kinetic chromogenic and turbidimetric).
- Bioburden - membrane filtration.
- Environmental monitoring (surface, viable/non-viable air).
- Water collection and sampling.
- Aseptic Technique.
- Gram Stain.
- GMP Documentation.
- Demonstrably functional understanding of a laboratory setting and Standard Operating Procedures (SOPs).
- Must be computer literate and able to navigate, conduct searches, and complete online forms on Personal Computer for the purposes of training, performance management, and self-service applications.
- Knowledge of cGMP manufacturing preferred.
- Knowledge of basic chemical and biological safety procedures.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Cassini at +1 215 531 5288 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-KC1
seeking a QC Analyst I - Microbiology with a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit the QC Analyst to their office in Minnesota.
This position will have a flexible, non-standard schedule, working from either Saturday-Wednesday with Thursday and Friday off, or Wednesday-Sunday with Monday and Tuesday off.
Job Responsibilities:
- Performing supportive activities for general lab readiness, laboratory equipment qualification, and method transfers.
- Conducting critical biological test methods, including samples generated for in-process, drug substance, and stability.
- Using a variety of laboratory instrumentation and computer systems to collect and record data, such as LIMS.
- Following SOPS to perform methods requiring precise analytical skills and understanding of biology and chemistry principles.
- Completing all testing, including all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintaining data integrity and ensuring compliance with company SOPs, specifications, and cGMP regulations.
- Exercising judgment within defined Quality Control procedures and practices to determine appropriate action.
- Initiating low severity level deviations, CAPAs, and change controls within the electronic Quality Management System.
- Participating in functional efforts involving teams to solve problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
- Authoring minor revisions to existing SOPs.
- Receiving general instructions on routine work and detailed instructions on new assignments.
- Performing equipment maintenance and calibrations as required.
Skills and Requirements:
- Experience in:
- Endotoxin (Charles River/Lonza methods; kinetic chromogenic and turbidimetric).
- Bioburden - membrane filtration.
- Environmental monitoring (surface, viable/non-viable air).
- Water collection and sampling.
- Aseptic Technique.
- Gram Stain.
- GMP Documentation.
- Demonstrably functional understanding of a laboratory setting and Standard Operating Procedures (SOPs).
- Must be computer literate and able to navigate, conduct searches, and complete online forms on Personal Computer for the purposes of training, performance management, and self-service applications.
- Knowledge of cGMP manufacturing preferred.
- Knowledge of basic chemical and biological safety procedures.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Cassini at +1 215 531 5288 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-KC1
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