What are the responsibilities and job description for the Senior Specialist, Quality Control position at Boehringer Ingelheim?
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 several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The basic purpose of this role is to maintain all systems in Quality Control department related to samples and data management. The Senior Specialist, Quality Control will manage sample life cycle from receipt to release.
Duties & Responsibilities
- Manages sample submission, testing and reporting of active ingredient, serials and stability samples tested by Quality Control. Includes providing information to QC department about samples from production (lead times, off test dates, special submissions, etc.).
- Prepares submissions to USDA for product release (APHIS Form 2008) and submission of samples (APHIS FORM 2020 - includes submission of reagents for testing when requested by CVB).
- Maintains the sample retention cage and retention related processes, such as database according to USDA Regulations and Boehringer Ingelheim Quality Directives.
- Acts as a Key User for the Laboratory Information Management System (LIMS) maintains the routine system activities such as daily test reports, sample testing and projects as well as acts as backup for LIMS Administrator.
- Creates and maintains KPI's for QC department.
- Acts as Dangerous Goods shipper for QC department.
- Authors and revises Standard Operating Procedures, Guidelines, and Product Test Specifications.
- Participates and / or facilitates in problem solving and troubleshooting for issues in QC department.
Requirements
Eligibility Requirements :
Desired Skills, Experience and Abilities
PDN-9e4105e1-b26b-48f8-b60c-ee9c8c462e7a
