Senior Specialist QA Operations

Bristol Myers Squibb • Indianapolis, IN

4d • $82,236 - $99,650 • Onsite

About The Position

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.

Requirements

• 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 or a related industry
• Experience working in a GMP aseptic manufacturing environment preferred.
• Experience working with FDA or other regulatory authorities is preferred.
• 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.

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.
• 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.
• 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.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, 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.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees