Specialist, QC Incoming Components

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The Role

Cruiserath Biologics are seeking to recruit a Specialist, QC Incoming Components with responsibilities for QC testing and support activities in the QC laboratory. Reporting to the QC Senior Manager, Incoming Materials, the QC Specialist provides support directly and indirectly to the QC laboratory.

Key responsibilities will include:

Manage Operations

• Performing routine lab analysis of materials/components, data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports and event reviews.

• Participate in regulatory audits as required.

• Execute and assist in technical transfer and co-validation activities.

• Perform instrument performance checks and calibration.

• Participate in troubleshooting testing and instrumentation issues.

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.

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.

• Problem-solving ability/mentality, technically adept and logical.

• Ability to write technical documents.

Required Qualification(s) and Desired Experience

• 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.

• Experience in Incoming Component technologies, FTIR, UV-Vis, Appearance and colour testing is preferable but not essential.

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 allowance, 27 days of annual leave, life assurance and on-site gym

#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

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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.

R1601161 : Specialist, QC Incoming Components