Bristol Myers Squibb
Summary
The Senior Specialist, QA Operations supports operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. This role provides oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures, ensuring compliance in operations to support clinical development and GMP commercial operations in line with RayzeBio policies, standards, procedures and current Good Manufacturing Practice (cGMP). The position also manages material and batch disposition activities and works closely with the Qualified Person (QP) as needed to facilitate release of EU doses.
Job Responsibilities
Build and maintain cross‑functional relationships to improve processes and resolve issues.
Provide quality oversight on manufacturing and validation activities.
Perform real‑time review of manufacturing records.
Conduct periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
Provide guidance on the handling of quality and shop floor activities.
Support the Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
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 applying appropriate notification to management as appropriate.
Participate as requested in the response team for audits and inspections by health authorities.
Education and Experience
BS/MS degree in a science related field (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 working in a GMP aseptic manufacturing environment is preferred.
Experience working with FDA or other regulatory authorities is preferred.
Skills and Qualifications
Expertise in GMP, quality, material and product 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 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.
Knowledge of US, EU and rest‑of‑world cGMP regulations and guidance.
Knowledge and proven experience in FDA, EMA, or other regulatory authorities.
Well‑practiced in exercising sound judgment in decision‑making.
Demonstrated prioritization and organization skills.
Physical Demands While performing the duties of this role, the employee is regularly required to sit, reach with hands and arms, talk or hear, and occasionally lift or move up to 30 pounds. Specific visual abilities required for this role include close vision and distance vision. Protective clothing, gloves, and safety glasses are required due to radioactive materials.
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.
Compensation Overview Indianapolis – RayzeBio – IN: $82,236 – $99,650 (annual base). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.
Benefits Medical, pharmacy, dental, and vision care. Well‑being programs such as BMS Living Life Better, employee assistance programs (EAP), financial well‑being resources, 401(K), disability and life insurance, supplemental health insurance, business travel protection and survivor support. Work‑life programs include paid national holidays and optional holidays, Global Shutdown Days, up to 120 hours of paid vacation, paid volunteer days, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave, family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Additional perks: tuition reimbursement and recognition program.
EEO Statement BMS is an equal opportunity employer. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. For more information, visit careers.bms.com/eeo-accessibility.
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Job Responsibilities
Build and maintain cross‑functional relationships to improve processes and resolve issues.
Provide quality oversight on manufacturing and validation activities.
Perform real‑time review of manufacturing records.
Conduct periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
Provide guidance on the handling of quality and shop floor activities.
Support the Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
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 applying appropriate notification to management as appropriate.
Participate as requested in the response team for audits and inspections by health authorities.
Education and Experience
BS/MS degree in a science related field (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 working in a GMP aseptic manufacturing environment is preferred.
Experience working with FDA or other regulatory authorities is preferred.
Skills and Qualifications
Expertise in GMP, quality, material and product 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 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.
Knowledge of US, EU and rest‑of‑world cGMP regulations and guidance.
Knowledge and proven experience in FDA, EMA, or other regulatory authorities.
Well‑practiced in exercising sound judgment in decision‑making.
Demonstrated prioritization and organization skills.
Physical Demands While performing the duties of this role, the employee is regularly required to sit, reach with hands and arms, talk or hear, and occasionally lift or move up to 30 pounds. Specific visual abilities required for this role include close vision and distance vision. Protective clothing, gloves, and safety glasses are required due to radioactive materials.
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.
Compensation Overview Indianapolis – RayzeBio – IN: $82,236 – $99,650 (annual base). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.
Benefits Medical, pharmacy, dental, and vision care. Well‑being programs such as BMS Living Life Better, employee assistance programs (EAP), financial well‑being resources, 401(K), disability and life insurance, supplemental health insurance, business travel protection and survivor support. Work‑life programs include paid national holidays and optional holidays, Global Shutdown Days, up to 120 hours of paid vacation, paid volunteer days, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave, family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Additional perks: tuition reimbursement and recognition program.
EEO Statement BMS is an equal opportunity employer. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. For more information, visit careers.bms.com/eeo-accessibility.
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