QC Specialist Incoming, Sample management & Incoming testing Packaging page is loaded
QC Specialist Incoming, Sample management & Incoming testing Packaging Apply locations: Boudry - CH
Time type: Full time
Posted on: Posted 2 Days Ago
Job requisition id: R1589027
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Role Overview The QC Specialist Incoming is part of the Sample Management & Incoming testing Packaging team, in the 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 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.
Key Responsibilities The QC Specialist Incoming is responsible for introducing new materials (packaging) into QC Laboratory. This individual plays a critical role in leading method development and verification/validation related to raw materials packaging as well as establishing incoming testing packaging specifications. 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).
Specific Duties Introduce new methods for packaging into QC Laboratory: 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, and operating procedures for packaging.
Establish incoming testing specifications for the release of packaging and document rationale for the establishment of testing.
Support with new equipment installation related activities.
Ensure training of QC personnel 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.
Perform trial packaging material assessment: 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.
Sampling activities: Verification of Sampling Plan in the system.
Updating procedures and improving processes.
Scheduling management.
Definition of Full and Reduce testing.
Deviations and laboratory investigation management: Act as Deviation Owner 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 a result of deviation/investigation.
Maintain the GMP status of QC incoming packaging operations and promote continuous improvement: Evaluate impact of compendial changes on applicable QC procedures and handle 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.
Assists with review, verification, and approval of data: Serve as technical reviewer of appropriate departmental procedures.
Review documentation as required by laboratory procedures.
Perform peer review as needed.
Promotes safe practices and behaviors: Report 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.
Qualifications 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 on 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.
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.
Travel: This position does not require travel (except for training purposes).
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