VetJobs
Sr. Specialist, QA Incoming Materials - Indianapolis, IN
VetJobs, Indianapolis, Indiana, us, 46262
Sr. Specialist, QA Incoming Materials - Indianapolis, IN
4 days ago Be among the first 25 applicants
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. 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.
Summary The Quality Assurance Incoming Material Disposition Senior Specialist is responsible for coordinating the receipt of deliverables to support the disposition of incoming materials such as consumables and raw materials at the RayzeBio Indianapolis, IN facility. This position will perform review of the disposition deliverables to support disposition of materials and batches within the inventory management systems and assure materials comply with all RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).
The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, and material disposition.
Job Responsibilities
Inspects consumables and raw materials per Standard Operating Procedures
Build and maintain cross functional relationships to improve processes and resolve issues
Performs Quality Assurance review of documentation to support disposition of incoming materials
Works closely with supply chain and manufacturing with regards to discrepancy reporting, investigations and CAPAs associated with nonconforming material as well as the incoming material process
Drafts, revises, and approves procedural documents and material specifications
Performs review for department SOPs and Material Specification Documents
Supports warehouse personnel with concerns/issues with received material
Participates in Master Data management and supports master data for incoming materials
Leads the Indianapolis site Material Review Board
Works with a cross functional team to process Supplier Change Notifications and determine appropriate actions needed
Responsible for the Supplier Complaint (SCAR) process for non-conforming material
Coordinates with internal and external stakeholders to troubleshoot issues when required
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation
Identify and report discrepancies from required work practices or procedures to management
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate
Participate as requested in the response team for audits and inspections by health authorities
Auto req ID 459276BR
Minimum Education Required: Bachelors
Additional Qualifications/Responsibilities Education and Experience
BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry
Experience with an Enterprise Resource Planning (ERP) system such as SAP is preferred
Experience working with FDA or other regulatory authorities is preferred
Skills and Qualifications
Expertise in GMP, Quality, and material disposition
Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
Team player who can work independently to achieve objectives in a fast-paced environment
Excellent verbal and written communication skills
Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired
Knowledge of US, EU and rest-of-world cGMP regulations and guidance
Knowledge and proven experience in FDA, EMA, or other regulatory authority
Well-practiced in exercising sound judgment in decision-making
Demonstrated prioritization and organization skills
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 an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.
Work Environment The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview Indianapolis - RayzeBio - IN: $82,236 - $99,650
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
City: Indianapolis
State: Indiana
Job Code: Pharmaceutical Pharmaceutical
Affiliate Sponsor: Bristol Myers Sqibb BMS
Salary Range: $75,000-$100,000
#J-18808-Ljbffr
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. 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.
Summary The Quality Assurance Incoming Material Disposition Senior Specialist is responsible for coordinating the receipt of deliverables to support the disposition of incoming materials such as consumables and raw materials at the RayzeBio Indianapolis, IN facility. This position will perform review of the disposition deliverables to support disposition of materials and batches within the inventory management systems and assure materials comply with all RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).
The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, and material disposition.
Job Responsibilities
Inspects consumables and raw materials per Standard Operating Procedures
Build and maintain cross functional relationships to improve processes and resolve issues
Performs Quality Assurance review of documentation to support disposition of incoming materials
Works closely with supply chain and manufacturing with regards to discrepancy reporting, investigations and CAPAs associated with nonconforming material as well as the incoming material process
Drafts, revises, and approves procedural documents and material specifications
Performs review for department SOPs and Material Specification Documents
Supports warehouse personnel with concerns/issues with received material
Participates in Master Data management and supports master data for incoming materials
Leads the Indianapolis site Material Review Board
Works with a cross functional team to process Supplier Change Notifications and determine appropriate actions needed
Responsible for the Supplier Complaint (SCAR) process for non-conforming material
Coordinates with internal and external stakeholders to troubleshoot issues when required
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation
Identify and report discrepancies from required work practices or procedures to management
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate
Participate as requested in the response team for audits and inspections by health authorities
Auto req ID 459276BR
Minimum Education Required: Bachelors
Additional Qualifications/Responsibilities Education and Experience
BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry
Experience with an Enterprise Resource Planning (ERP) system such as SAP is preferred
Experience working with FDA or other regulatory authorities is preferred
Skills and Qualifications
Expertise in GMP, Quality, and material disposition
Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
Team player who can work independently to achieve objectives in a fast-paced environment
Excellent verbal and written communication skills
Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired
Knowledge of US, EU and rest-of-world cGMP regulations and guidance
Knowledge and proven experience in FDA, EMA, or other regulatory authority
Well-practiced in exercising sound judgment in decision-making
Demonstrated prioritization and organization skills
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 an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.
Work Environment The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview Indianapolis - RayzeBio - IN: $82,236 - $99,650
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
City: Indianapolis
State: Indiana
Job Code: Pharmaceutical Pharmaceutical
Affiliate Sponsor: Bristol Myers Sqibb BMS
Salary Range: $75,000-$100,000
#J-18808-Ljbffr