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QA Deviation Reviewer, Approver Specialist
QA Deviation Reviewer, Approver Specialist-September 2024
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Sep 21, 2024
ABOUT BRISTOL MYERS SQUIBB
Bristol Myers Squibb is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About QA Deviation Reviewer, Approver Specialist

  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 rich in diversity. 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 .

  Shift: Mon - Fri (8:30AM - 5:00PM)

  REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.

  Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.

  Knowledge of audit and inspection readiness.

  Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.

  Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions.

  Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.

  Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, resource allocation, and analytical thinking

  Must possess an independent mindset and tenacity.

  Routinely recognizes Quality issues and solves problems

  Follows established procedures and performs work as assigned.

  Ability to interpret results and situations and articulate recommendations for resolution.

  Capable of providing input within the department and cross functional teams.

  Builds relationships internally within and with cross functional teams.

  Contributes to goals within the work group.

  Able to prepare written communications and communicate problems to management with clarity and accuracy.

  Able to write and review reports with clarity and brevity.

  Able to effectively multi-task.

  Knowledge of US and global cGMP requirements.

  Understanding of aseptic manufacturing processes.

  Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.

  Excellent verbal and written communication skills.

  Education and Experience:

  B.S. degree required;

  Minimum 2 years of experience in the pharmaceutical or related industry.

  Preferred experience in Quality and/or Investigation departments.

  DUTIES AND RESPONSIBILITIES:

  Supports all activities for the Quality Operations group.

  Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.

  Ensure procedures are adequate to review and confirm appropriateness of raw data.

  Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

  Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.

  Supports audit and inspections in various capabilities.

  Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.

  Assess global standards/policies and emerging regulations.

  Ensure the site stability program meets global and regulatory requirements.

  Must be skilled in planning and organizing, decision-making, and building relationships.

  Able to effectively multi-task.

  WORKING CONDITIONS (US Only): 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. Lighting and temperature are adequate and there are no abnormal conditions caused by

  noise, dust, etc.

  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.

  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.

  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 an inclusive culture, promoting diversity 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

  Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

  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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

  BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

  BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

  Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

  Company: Bristol Myers Squibb

  Req Number: R1577782

  Updated: 2024-01-22 15:05:38.091 UTC

  Location: Summit,New Jersey

  Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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