National Guard Employment Network
Specialist, Quality Assurance Operations - Indianapolis, IN
National Guard Employment Network, Indianapolis, IN, United States
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required in a multi-phase and commercial radiopharmaceutical facility. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
*This is an onsite position at Rayzebio's Indianapolis, IN site*
Key Responsibilities:
Quality floor support of complex manufacturing activities, including line release, alarm review, logbook review, etc. Gowning is required when working in ISO classified spaces.
Build and maintain cross functional relationships to improve processes, resolve issues, and facilitate uniform quality standards
Performs walkthroughs of GMP areas documenting observations and areas of concern
Performs training on routine facility Quality tasks for new team members
Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs
Assures all electronic and paper documentation, which requires QA review is in compliance with site procedures and protocols, cGMP regulations, and other industry guidelines
Authors and revises Quality-specific SOPs and may provide Quality review and approval of manufacturing related SOPs
Supports the Quality review and closure of manufacturing deviations, corrective and preventative actions, and change controls, including evaluation of root cause analyses, as well as impact and risk assessments
Supports the Quality review and closure of Out-of-Specification results and Lab Events identified during Quality Control testing of raw materials and manufactured drug products
Supports release of incoming raw materials
Other duties as assigned
No travel required
Additional Qualifications/Responsibilities
Education and Experience:
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred, advance degree a plus.
A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality preferred.
Knowledge of late phase and commercial GMP aseptic manufacturing, analytical and Microbial testing is highly desirable.
Knowledge of US and EU cGMP regulations.
Knowledge of electronic or paper batch record systems and other electronic systems applicable to laboratory test result generation, investigations, inventory management, and equipment tracking and maintenance is desirable.
ASQ or ISO certification a plus/
Skills and Qualifications:
Highly motivated and organized professional with the ability to work independently
Working knowledge of 21 CFR Parts 11, 210, 211 and EU regulations
Personable with strong communication skills and ability to multi-task
Excellent professional ethics, integrity, and ability to maintain confidential information
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory and ISO classified environments with radioactive materials, where protective clothing, gloves, and safety glasses may be required.
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required in a multi-phase and commercial radiopharmaceutical facility. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
*This is an onsite position at Rayzebio's Indianapolis, IN site*
Key Responsibilities:
Quality floor support of complex manufacturing activities, including line release, alarm review, logbook review, etc. Gowning is required when working in ISO classified spaces.
Build and maintain cross functional relationships to improve processes, resolve issues, and facilitate uniform quality standards
Performs walkthroughs of GMP areas documenting observations and areas of concern
Performs training on routine facility Quality tasks for new team members
Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs
Assures all electronic and paper documentation, which requires QA review is in compliance with site procedures and protocols, cGMP regulations, and other industry guidelines
Authors and revises Quality-specific SOPs and may provide Quality review and approval of manufacturing related SOPs
Supports the Quality review and closure of manufacturing deviations, corrective and preventative actions, and change controls, including evaluation of root cause analyses, as well as impact and risk assessments
Supports the Quality review and closure of Out-of-Specification results and Lab Events identified during Quality Control testing of raw materials and manufactured drug products
Supports release of incoming raw materials
Other duties as assigned
No travel required
Additional Qualifications/Responsibilities
Education and Experience:
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred, advance degree a plus.
A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality preferred.
Knowledge of late phase and commercial GMP aseptic manufacturing, analytical and Microbial testing is highly desirable.
Knowledge of US and EU cGMP regulations.
Knowledge of electronic or paper batch record systems and other electronic systems applicable to laboratory test result generation, investigations, inventory management, and equipment tracking and maintenance is desirable.
ASQ or ISO certification a plus/
Skills and Qualifications:
Highly motivated and organized professional with the ability to work independently
Working knowledge of 21 CFR Parts 11, 210, 211 and EU regulations
Personable with strong communication skills and ability to multi-task
Excellent professional ethics, integrity, and ability to maintain confidential information
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory and ISO classified environments with radioactive materials, where protective clothing, gloves, and safety glasses may be required.