Logistics Analyst, ONSITE, Fremont CA

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Provides technical oversight across Quality Control (QC) and Inbound operations, including monitoring and coordination of all inbound and inspection scheduling activities. Oversees KPIs and performance metrics for both functional areas. Leads quality and compliance activities related to new or non‑routine test methods, specifications, plans, reports, forms, and SOPs. Operates with limited supervision in accordance with established QC procedures and standard operating practices. Serves as the primary point of contact for outgoing sample shipments and related activities.

Monday-Friday: 7:30am-4:30pm PST

Duties & Responsibilities

• Manage sample shipments via various Boehringer Ingelheim approved freight carriers: small parel, LTL, FTL
• Work with Inbound Logistics and verify applicable documentation and material
• Documents work according to cGMP and cGDP.
  Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Establishes GMP areas according to predefined standards (5s). Group representative on simple or routine equipment qualifications.
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on complex topics and scientific principles as needed. Establishes training curricula and train others as a SME. Implements new training procedures and drives continuous improvement.
• Work cross functionally with Trade Compliance teams to manage regulated shipments
• Perform Inbound GMP receipts
• Support all other logistics functions including, but not limited to cycle counting, on call, safety initiatives, etc.
• Coordinates and reviews analytical testing of bulk drug substance and drug product in a multi-product facility. Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Coordinates routine maintenance activities in both QC and warehouse areas. Identifies and implements fundamental improvements to processes and compliance activities.
• Group representative on simple or routine equipment qualifications. Serves as QC subject matter expert (SME) representing the department during audits for 3-5 topics within group. Executes with oversight moderately complex QC related compliance deliverables within different areas of the Quality System (deviations, investigations, OOS and CAPAs and change controls). Managing projects of core, platform processes within Quality and Logistics.
• Perform incidental related duties as assigned or requested

Requirements

• Bachelors Degree in a science or engineering related field Or Masters Degree (preferred)in a science or engineering related field
• BS/BA with 4 yrs year work experience in analytical testing in a GMP regulated industry.
• MS/MA, with 2 years work experience in Analytical testing in a GMP regulated industry.
• Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
• Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
• Proven experience with technical review, analysis and interpretation of scientific data
• Track record of troubleshooting and applying the scientific method to solve technical problems
• Experience with computer-based systems and ideally experience with process control systems
• Previous experience authoring SOPs, methods, and/or work instructions
• Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc)
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Experience interacting with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise
• Experience troubleshooting technical problems and/or equipment
• Demonstrated ability to lead projects of low complexity

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

Compensation Details

The base salary range for the Logistics Analyts position is $74,800 to $112,000.

The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.