Analyst II, QC Microbiology - RESILIENCE US INC
Hamilton, OH
About the Job
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary:
This position performs tasks related to the quality of pharmaceutical products in the Microbiology Department. This is a site-based role in West Chester, OH.
Position Responsibilities:
Documents and performs testing on a range of samples, including raw materials, in-process, finished products, stability samples, water, gas, and environmentalsamples.
Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
Complete required training and may train others.
Conduct troubleshooting activities.
Gather, organize, and communicate operational information to others.
Facilitate team meetings to discuss progress, initiatives, and/or other matters.
Actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
Assist with coordinating activities of support groups.
Identifies trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
Demonstrates proficiency on authoring Quality records (Deviations, CAPAs, and Change Controls).
Identify temporary and permanent fixes to address issues.
Alert supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures).
Collect, record, and report metrics.
Monitor equipment and/or systems for performance and problem indicators.
Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
Perform logbook reviews.
Lead or participate in process improvement activities and teams to meet strategic goals.
Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
Interact with regulatory agency individuals during audits and inspections, when necessary.
Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
Coordinate qualification activities.
Perform routine sampling activities on the facility utilities.
Recommend compliance resolutions to management.
Minimum Qualifications:
Working knowledge of cGXP requirements and a strong familiarity with production operations.
Good problem--solving skills.
Preferred Qualifications:
Bachelor's degree in biology, microbiology, or related discipline.
At least 2 years of laboratory experience in the pharmaceutical industry.
Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.
This position may also include the following conditions:
This role is primarily non-sedentary. May include but not limited to standing, walking, repetitive motion, and chemical usage.
All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufactur
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary:
This position performs tasks related to the quality of pharmaceutical products in the Microbiology Department. This is a site-based role in West Chester, OH.
Position Responsibilities:
Documents and performs testing on a range of samples, including raw materials, in-process, finished products, stability samples, water, gas, and environmentalsamples.
Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
Complete required training and may train others.
Conduct troubleshooting activities.
Gather, organize, and communicate operational information to others.
Facilitate team meetings to discuss progress, initiatives, and/or other matters.
Actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
Assist with coordinating activities of support groups.
Identifies trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
Demonstrates proficiency on authoring Quality records (Deviations, CAPAs, and Change Controls).
Identify temporary and permanent fixes to address issues.
Alert supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures).
Collect, record, and report metrics.
Monitor equipment and/or systems for performance and problem indicators.
Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
Perform logbook reviews.
Lead or participate in process improvement activities and teams to meet strategic goals.
Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
Interact with regulatory agency individuals during audits and inspections, when necessary.
Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
Coordinate qualification activities.
Perform routine sampling activities on the facility utilities.
Recommend compliance resolutions to management.
Minimum Qualifications:
Working knowledge of cGXP requirements and a strong familiarity with production operations.
Good problem--solving skills.
Preferred Qualifications:
Bachelor's degree in biology, microbiology, or related discipline.
At least 2 years of laboratory experience in the pharmaceutical industry.
Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.
This position may also include the following conditions:
This role is primarily non-sedentary. May include but not limited to standing, walking, repetitive motion, and chemical usage.
All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufactur
Source : RESILIENCE US INC
