Senior Specialist, QC Quality Systems
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
Drug products linked to this role
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 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
The Role
BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, QC Quality Systems (Lead Investigator) on a FIXED TERM contract (12 months), reporting to the QC Shared Services Manager. The QC Quality Systems Senior Specialist will be part of a team who are responsible for supporting the Quality Control team with Investigations and Change Controls
Key Duties and Responsibilities:
Lead and manage QC Investigations assigned
Facilitate root cause analysis and problem solving sessions
Complete the generation of associated investigation reports
Determine and create CAPA’s, Effectiveness Reviews, and Supplemental Tasks as required
Present investigations at IRB to senior management
Leading and coordinating the initiation, implementation, and closure of QC Change Controls
Ensuring the timely completion of all activities related to these quality systems
Collation of metrics/KPI’s and generation of associated dashboard read-out
Communication with BMS local and global stakeholders
Lead huddles, meetings, conference calls and provide read-outs
Participate in the OpEx strategy and support process improvements
Participate in internal and external audits
Support additional QC shared services activities, as required
Qualifications, Knowledge and Skills Required:
Proficiency in communication and collaboration at a variety of levels
Proven success working well in a team environment with flexibility to react to changing business needs
Demonstrated problem solving, project management ability
Excellent time management and organizational skills
Excellent technical writing skills
Previous investigations experience is an asset.
Ability to research and have an excellent understanding of new areas/tasks/assays under investigation promptly
Education minimum of a B.Sc. Biochemistry or related discipline
At least 3 years’ experience, in a GMP laboratory setting ideally within a biologics laboratory
A minimum of 1 years’ experience with demonstrated effectiveness using quality systems (investigations/change controls – Trackwise/Infinity) in a FDA and EMA regulated environment
Knowledge of biologics QC testing (Separations, Bioanalytical, Microbiology, Raw Materials and Stability testing) is desirable
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
BMSBL
#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.
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.
R1600986 : Senior Specialist, QC Quality SystemsExplore related positions you might be interested in
We'll notify you when matching roles are posted.
Interviewed at Bristol Myers Squibb?
Help others prepare — share your experience anonymously.
PHARMACEUTICAL
Small Molecules, Biologics
Upgrade to Pro to access salary benchmarks and market rate data and other premium pharma intelligence.
Upgrade to Pro — $25/moUpgrade to Pro to access all 5 linked drug products and competitive intelligence and other premium pharma intelligence.
Upgrade to Pro — $25/mo