Quality Specialist, PDQ Quality Operations Support at Bristol Myers Squibb

New Brunswick, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Apr, 26

Salary

101671.0

Posted On

19 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP Regulations, Interpersonal Skills, Communication Skills, Attention to Detail, Leadership Skills, Organizational Skills, Collaboration, Regulatory Compliance, Manufacturing Support, Problem Solving, Process Improvement, Supplier Management, Inspection Readiness, Documentation, Change Management

Industry

Pharmaceutical Manufacturing

Description

Working with Us 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. Key Responsibilities and Major Duties 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) Professional Experience and Qualifications 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. Experience in R&D environment is highly desirable. 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 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: New Brunswick - NJ - US: $83,900 - $101,671 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. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: 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: The 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. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities 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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1597554 : Quality Specialist, PDQ Quality Operations Support Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities. Perform QA manufacturing floor support activities to ensure compliance with current Good Manufacturing Practices (cGMP).