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The Role
BMS Cruiserath Biologics is seeking to recruit on a permanent contract Senior Specialist, QA Operations, reporting Senior Manager, QA Lead, QP Operations, QP Operations.
Key Duties And Responsibilities
Support the Qualified Person with the Batch Certification function
Prepare and review batch documentation packages for QP release as per SOP requirements
Liaise with BMS Supply Chain and Quality colleagues to ensure that disposition lead times are consistently met
Update SOPs, controlled documents i.e. FORMS and OJTs
Assist in new product introduction activities as required
Provide training to new team members
Support the site inspection readiness program for corporate and regulatory inspections
Identify and make recommendations for improvements to ensure continuous improvement
Participate in site activities associated with the QMS (e.g. Change Control, Self-Inspections, Quality Agreement updates, Customer Complaints, Product Quality Record Reviews) as required
Ensure that all work carried out follows the required standards conforming to SOPs, regulatory regulations and guidelines, and Quality Agreements
Perform additional team tasks as agreed to support effective running of the function
Qualifications and Experience required
A degree in science, engineering or related discipline is essential. A minimum of 1-2 years' experience in pharmaceutical / biopharmaceutical industry
Experience using data or electronic document management systems (DCA, Trackwise, Infinity, and SAP)
Strong working knowledge of Microsoft Excel and PowerPoint
Ability to work on his/her own initiative in addition to working as part of a team
Good organizational skills and attention to detail
Ability to handle multiple assignments and changing priorities
Ability to learn and utilize computerised systems for daily performance of tasks
Ability to prioritize, manage multiple tasks, and meet deadlines
Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level. The BMS Behaviors are Passion, Innovation, Accountability and Speed.
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, but not limited to, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.
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 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.
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