Be an early applicantLess than 25 applicants
Boehringer Ingelheim · 2 days ago
SR QC Associate, QC Lab General
Fremont, CA
Full-time
Onsite
Mid Level
2+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesBiotechnologyHealth Care
Insider Connection @Boehringer Ingelheim
Responsibilities
Executes independently, with adequate training, three to five (3-5) analytical testing methods with different analytical principles under minimum oversight by qualified staff
Manages and reviews fundamental tasks such as buffer prep, TCU maintenance, and cleaning
Identifies and implements fundamental improvements to lab processes compliance activities
Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs)
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
Maintains and improves lab areas according to predefined standards (5s)
Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification
Conducts group trainings on compliance topics and scientific principles as needed
Performs testing and review within several different analytical technologies
Reviews and trends analytical data and compliance processes to identify out of trends
Authors routine compliance documents
Identifies process anomalies and areas for improvement for operations
Provides compliant and smart solutions for moderately complex method and testing issues
Coordinates work within the team and cross functionally
Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place
Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions
Trains other associates and technicians on methods and compliance
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
High School Diploma with six (6) years’ experience of experience in cGMP regulated industry or equivalent
OR
Associate Degree with four (4) years’ experience of experience in cGMP regulated industry or equivalent
OR
Bachelor’s Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent.
Previous QC Experience preferred.
Experience with 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
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
Proven experience with technical review, analysis, and interpretation of scientific data
Strong written and verbal communication skills
Experience with computer-based systems and ideally experience with process control systems
Previous experience to read and understand SOPs and/or methods and document work in a written format applying cGMP/GDP standards
Ability to work as part of a high performing team and collaborate effectively with staff
Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
Strong focus on execution of non-routine analytical methods or processes
Strong technical knowledge in analytical methods
Ability to work independently with very little supervision
Champions problem resolution
Knows when to escalate to line management
Benefits
Competitive compensation and benefit programs
Healthy working environment
Meaningful work
Diversity and inclusion
Mobility
Networking
Work-life balance
Company
Boehringer Ingelheim
Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.
Founded in 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10,001+ employees
H1B Sponsorship
Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (8)
2022 (10)
2021 (16)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
SVP, Head of Biopharma Austria
Clive Wood
Senior Vice President
Recent News
Business Wire
2024-06-03
Global Legal Chronicle
2024-05-31
http://www.zdnet.com/
2024-05-28
Company data provided by crunchbase
