QC Specialist, Materials Management, Incoming Components

3 weeks ago


Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

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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.

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 .

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state-of-the-art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie.

Position Summary

Cruiserath Biologics is currently seeking a Biologics QC Specialist - QC Materials Management Services Team Lead to oversee QC testing and support activities within the QC laboratory. Reporting to the QC Materials Manager, Incoming Components, the Senior Specialist will play a key role in supporting the QC laboratory both directly and indirectly.

Key Responsibilities Will Include

Manage Operations

  • Assisting with qualification of laboratory instruments.
  • Participate in regulatory audits as required.
  • Performing routine lab analysis, data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports and event reviews.
  • Execute and assist in technical transfer and co-validation activities.
  • Perform instrument performance checks and calibration.
  • Participate in troubleshooting complex testing and instrumentation issues.
  • Testing of materials/components to meet attainment and release metrics.
  • Support the QC Laboratory with the testing and release of QC samples.

Manage Information
  • Assisting in creating, updating and issuing documentation, including SOP's, as required.
  • Accurately documenting laboratory work adhering to best practice documentation behaviours and GMP level of quality.
  • Complete peer review of documented lab results, logbooks, and associated documents to ensure testing has been completed in compliance with procedures.

Safety
  • Prioritise safety in every aspect of the role.
  • Engage fully with site safety guidelines and culture.
  • Lead by example in promoting and displaying good safety behaviours.

Teamwork
  • Succeed as part of a laboratory-based team, to achieve team goals for testing and release of QC Samples.
  • Participate in cross functional teams to deliver department and site goals.
  • Provide support to other departments to ensure site schedules are adhered to.
  • Development
  • Participate in and perform training where required.
  • Participate in and perform all team based activities to meet site demands.

Housekeeping
  • Maintain lab to highest standards to ensure all assigned areas are maintained by designees.
  • Perform all other activities as indicated by Supervisor.

Designee Responsibilities

The designee can act on behalf or in place of the Immediate Supervisor/Manager in the full range of Department activities provided the selected Immediate Supervisor/ Manager is satisfied of the capability of the designee to do so and appropriate advance consultation has taken place.

Required Competencies
  • Ability to understand and follow procedures.
  • Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
  • Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
  • Attention to detail and demonstrate organizational skills.
  • Ability to manage multiple assignments while meeting timelines.
  • Knowledge of basic electronic systems (email, MS Office, etc.) and lab data systems (e.g. LIMS) required.
  • Ability to interpret and apply cGMPs, Compendia regulatory requirements and industry best practices.
  • Excellent organizational and critical thinking skills.
  • Is considered a fully independent analyst capable of executing tasks with no supervision.
  • Problem-solving ability/mentality, technically adept and logical.
  • Ability to write technical documents.

Required Qualification(s) and Desired Experience
  • BS degree in scientific area with a minimum of 1 years' experience in the (bio) pharmaceutical industry.
  • The QC Specialist, QC Materials, Incoming Components should hold a minimum of a BSc. in science or related discipline. 1 years pharmaceutical testing experience is preferable but not a requirement.
  • Experience in working as part of a team, project management and activity scheduling.
  • Experience in analytical testing and release is required.
  • Experience in Incoming Component technologies, FTRI, UV-Vis, Appearance and color testing is preferable but not essential.

BMS Biopharma Behaviours

The qualified candidate demonstrates characteristics of our BMS Biopharma Behaviors. For more details refer to InSite BMS Website/ People and Performance/BMS Biopharma Behaviors.

Why You Should Apply
  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees
  • You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical assurance, 27 day annual leave, life assurance and on-site gym

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 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

Responsibilities

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.

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.

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.

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/

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

Seniority level
  • Seniority levelAssociate
Employment type
  • Employment typeFull-time
Job function
  • Job functionManagement and Manufacturing
  • IndustriesPharmaceutical Manufacturing

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