Sr. Specialist, QA Operations - Indianapolis, IN

VetJobs; Indianapolis (IN); On-site; USD 75,000 - 100,000; Full time

Job summary

RayzeBio in Indianapolis, IN, seeks a Senior QA Operations specialist to oversee quality in a radiopharmaceutical facility. You will supervise shop floor activities, disposition materials and batches, and ensure compliance with cGMP standards.

Ideal candidates have 5+ years in QA/compliance in pharma, BS/MS in a science field, and strong communication skills to support investigations and regulatory interactions.

Qualifications

• BS/MS degree in science related field; 5+ years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry.
• Experience in GMP aseptic manufacturing and familiarity with FDA/EMA regulations is preferred.
• Excellent written and verbal communication; capable of independent work in a fast-paced environment.

Responsibilities

• Provide quality oversight on shop floor manufacturing and validation activities.
• Review and approve Deviations, CAPAs, Change Controls, and Batch Records.
• Perform real time review of manufacturing records and quality control documentation.
• Guide QA disposition processes ensuring all documents meet procedures and specs.
• Collaborate with regulatory authorities as needed and support audits and inspections.

Skills

GMP knowledge

Quality assurance

Documentation review

Communication skills

Teamwork

Regulatory knowledge

Education

BS/MS in science-related field

Job description

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. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

Summary

The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with 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, Batch Records, and Material and Lot Disposition. This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• 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.
• Perform 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 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.
• Uses AI tools to enhance individual productivity and quality of work.

Decision Making Responsibilities

• 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

481143BR

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 Working In a GMP Aseptic Manufacturing Environment Preferred

Experience working with FDA or other regulatory authorities is preferred.

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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 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 thisjob, 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 thisjobincludeclose vision and distance vision.

WorkEnvironment

The noise level in theworkenvironment 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

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 Category

Operations

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

$75,000-$100,000