Bristol Myers Squibb
Bristol Myers Squibb is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
PURPOSE AND SCOPE OF POSITION:
The Senior Specialist is responsible for day-to-day QA Document Control operations at the Summit, NJ site, in accordance with Cell Therapy Development & Operations (CTDO) policies, standards, procedures and global cGMPs. The position executes Document Administration activities including but not limited to: Review and maintenance of controlled documents Periodic Review of quality documentation; review and approval of site-specific procedures. This position reports to the Manager of S12 Quality System Documentation Administration.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Leads communication regarding potential issues to others in department. Coaches employees to bridge knowledge gap;
- Possesses strong authorship; able to write and critically review reports. Provides guidance to others in technical writing and in interpretation of complex data;
- Fosters a team culture dedicated to enhancing customer satisfaction and building business partner relationships;
- Must be action Orientated with an independent mindset;
- Possesses conflict management techniques/ideas designed to reduce the negative effects of conflict and enhance the positive outcomes for all parties involved.
- Demonstrates ability to plan/organize and allocate resources;
- Must have GMP, Quality and risk management knowledge;
- Effectively prepares and conveys data analysis to management and others within group with clarity and accuracy;
- Possesses broadening technical knowledge and is able to analyze complete data in areas specific to job function at intermediate level;
- Contributes to the design and implementation of quality electronic documentation systems and practices;
- Demonstrates proficiency with PC-based office computers and standard Microsoft Office applications;
- Demonstrates ability to maintain current knowledge of applicable regulations and other regulatory changes.
Education and Experience:
- Relevant college or university degree preferred.
- Minimum 5 years of relevant industry experience, of which 2+ years of Document Control experience, is required.
- Experience with Veeva systems is preferred.
- Equivalent combination of education and experience acceptable.
- Previous experience in a gene or cell therapy facility is preferred (CAR T a plus).
- An equivalent combination of education and experience may substitute.
DUTIES AND RESPONSIBILITIES:
- Completes more complex tasks with moderate direction;
- Completes routine tasks with no supervision;
- Work is self-directed;
- Executes non-routine decisions in their subject matter area;
- Participates in cross-functional teams, as subject matter expert for electronic documentation systems.;
- Consulting supervisor for direction on managing personnel issues;
- Ability to fully interpret complex results and situations and articulate recommendations for resolution.
- Recognizes risk and develops contingency plans;
- Understands continuous improvement and improves efficiency and productivity within the group or project;
- Provides input within the function and cross-functional teams;
- Leverages relationships internally within function and with cross-functional teams and supports cross-functional objectives.
- Manages conflict issues with internal customers and able to recognize conflict and notify management with proposed recommendation for resolution;
- Show basic negotiation skills within work group and team;
- Demonstrates coaching skills and assists manager in ensuring staff are properly trained on controlled, approved GMP and Document Control procedures;
- Escalates concerns/ issues to Document Administration Management.
- Document Administrator for the global electronic GMP/GDP documentation system in compliance with regulatory and BMS requirements;
- Contributes to effective documentation system KPIs, metrics, and proactive issue identification and resolution;
- Ensures that documentation complies with established electronic documentation system standards;
- Provides support during internal and health authority inspections of site facility;
- Executes documentation system-related Quality Systems Objectives as assigned;
- Serve as a Document Control Reviewer/Approver on documentation, managed through the electronic GMP/GDP documentation management system;
- Assists with maintenance and administration of procedures related to job function;
- Systematizes and streamlines document workflows;
- Provides end-user training on electronic document management systems;
- Supports Quality Systems harmonization efforts across the CTDO organization;
- Performs other tasks as assigned.
WORKING CONDITIONS (US Only):
- The incumbent will be working 80% to 90% of the time in an office environment.
- The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
- The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
- Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10%of the time. Light to moderate lifting may be required, up to 25 lbs. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. Extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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