Quality Specialist, PDQ Quality Operations Support

Bristol Myers Squibb • New Brunswick, NJ

1d • Onsite

About The Position

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. Read more: careers.bms.com/working-with-us . Principal Objective of the Position Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities, and other GMP support areas. Provide Quality on the floor in-Process support during manufacturing operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Performs QA manufacturing floor support activities within the Clinical Supply Operations areas to ensure compliance with all principle of current Good Manufacturing Practices (cGMP). Support material and component release for clinical drug product manufacturing.

Requirements

• Knowledge of science generally attained through studies resulting in a B.S., in chemistry, pharmacy or biology or a related pharmaceutical science.
• Minimum of 3-5 years’ experience in pharmaceutical quality.
• Demonstrated effectiveness in quality assurance operation and compliance of clinical drug product and supplier management in an FDA and EMA regulated environment.
• Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations as they apply to clinical supplies.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Ability to provide innovative, compliant ideas or alternate approaches which create value.
• Ability to work on multiple projects/initiatives at any given time
• Highly collaborative, possess a track record of building and maintaining cross-functional relationships, and able to communicate effectively.
• Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
• Demonstrates knowledge and experience in cGMP regulations.
• Proficient in Desktop Applications (MS Word/Excel/PowerPoint/SharePoint)
• Excellent verbal and written communication skills
• Strong Interpersonal and organizational skills
• #LI-ONSITE

Nice To Haves

• Experience in R&D environment is highly desirable.

Responsibilities

• Performs QA Manufacturing Support Program activities and upholds the program’s principles and initiatives.
• Performs program implementation throughout CSO and other GMP support areas.
• Perform walkthroughs and spot checks of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.
• Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs.
• Perform parenteral AQL inspections.
• Responsible for timely release of raw materials, and components
• Assists in the management of change notification and complaints from suppliers to conform cGMPs as applicable
• Support periodic assessment of Clinical Supply Operations for Global Audit and Regulatory Agency inspection readiness.
• Evaluate and respond to observation and CAPA trends to ensure compliance with cGMP regulations and BMS procedures.
• Provides instruction and guidance on quality issues and serves as a resource for the site.
• Supports site operations during regulatory agency and third party inspections.
• Supports continuous improvement initiatives and drives simplification of processes
• Adherence to BMS core behaviors.
• (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Benefits

• 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.
• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

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