- Represent QC in cross-functional project teams supporting New Product Introductions, Material Qualification and Material Risk Assessment processes for packaging.
- Lead and support method verification for packaging materials, both internally and externally with contract testing laboratories.
- Write analytical methods, verification protocols and reports, specifications, operating procedures for packaging.
- Establish incoming testing specification for the release of packaging and document rational for the establishment of testing.
- Support with new equipment installation related activities.
- Ensure training of QC personal on new incoming testing methods and procedures.
- Support feasibility experimental work, as needed.
- Support QC New Product Introduction & Investigations team in the introduction of new materials.
- Work collaboratively with QC NPII, QC Commercial Drug Product and other cross-functional teams on testing requirements and sampling plans.
- Coordinate testing of Trial material.
- Participate in cross-functional teams meeting and provide trial material assessment QC progress.
- Verification of Sampling Plan in the system
- Updating procedures and improving processes
- Scheduling management
- Definition of Full and Reduce testing (APIs and Excipients).
- Act as Deviation Owner or lead investigator for QC incoming packaging deviations.
- Work cross-functionally with impacted areas to define appropriate and effective corrective and preventive actions.
- Ensure timely and compliant closure of QC deviations/lab investigations and CAPA in accordance with Bristol Myers Squibb procedures.
- Escalate issues requiring management decision in a timely manner.
- Provide appropriate level of reporting and communication on the assigned deviation/lab investigations at Quality governance forums.
- Present deviations in audits/inspections conducted by regulatory agency representatives.
- Authors, reviews, and approves complex GMP documentation such as standard procedures, work practices, training plans, and reports as result of deviation/investigation.
- Evaluate impact of compendial changes on applicable QC procedures and handles change controls, as required.
- Own or support change controls related to incoming packaging testing methods changes.
- Identify and lead continuous improvement initiatives related to QC incoming packaging activities.
- Serve as technical reviewer of appropriate departmental procedures.
- Review documentation as required by laboratory procedures.
- Perform peer review as needed.
- Report immediately incidents to Environmental, Health and Safety department; participate in investigations and identify measures to prevent similar accidents in the future.
- Demonstrate Bristol Myers Squibb values.
- Communicate effectively with management regarding complex issues.
- Perform other tasks as assigned and project work.
- Federal certificate in science or equivalent combination of education training and experience.
- Good knowledge of quality control operations in a GMP-regulated environment.
- Minimum 5 years of work experience in a GMP environment or regulated industry.
- Advanced understanding of pharmaceutical regulatory requirements (cGMPs, JP, JPE, USP and Ph. Eur) and their impact to incoming material operations.
- Advanced understanding of technical capability of instrumentation, software and techniques used in Incoming testing packaging.
- Experience in analytical method transfers and analytical method validation/verification is a plus.
- Experience of analytical testing according to Ph. Eur., JP and USP requirements is a plus.
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio).
- Good knowledge of Data Integrity principles.
- Effective verbal communication skills, ability to interact with different levels of the organization and other departments.
- Effective technical writing skills, experience writing of GMP documents (procedures, protocols, plans and reports) as well as deviations.
- Professional command of French and English, verbal and written.
- Proven analytical and problem-solving skills.
- Ability to work independently and compliantly.
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Specialist Incoming, Sample Management - Boudry, Schweiz - Bristol Myers Squibb
Beschreibung
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.
The QC Specialist Incoming is part of the Sample Management & Incoming testing Packaging team, in Quality Control department, at BMS Boudry.
This team is responsible for the management of all QC samples (from receipt to destruction), visual testing of samples, preliminary investigations and lead investigation on samples associated with product complaints, stock management and ordering of consumables and laboratory equipment, support activities for QC department and activity related to incoming testing packaging.
The QC Specialist Incoming is responsible for introducing new materials (packaging) into QC Laboratory. You will play a critical role in leading method development and verification/validation related to raw materials as well as establishing incoming testing packaging specification.
QC Specialist Incoming will also participate in projects relating to laboratory safety, new products, and continuous improvement.
All activities will be performed in full compliance with laboratory procedures and safety rules (EHS) as well as Good Documentation and Good Manufacturing Practices (GDP and GMP).
Finally, the QC Specialist Incoming is supporting activities related to the Pharmacopeia compendial review for packaging, evaluates impact of compendial changes on applicable QC procedures, handles associated change controls and manages Raw material sampling activities (including full and reduce testing).
Duties/Responsibilities:
Introduce new methods for packaging into QC Laboratory:
Perform trial packaging material assessment:
Sampling activities:
Deviations and laboratory investigation management:
Maintain the GMP status of QC incoming packaging operations and promote continuous improvement:
Assists with review, verification, and approval of data:
Promotes safe practices and behaviors:
Qualifications:
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", 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
BMS has a diverse 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 . Visit 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.
