SR QC Associate, QC Lab General, Fremont CA

Description

The SR QC Associate, QC Lab General at Boehringer Ingelheim is assigned to QC functional or technical areas such as HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification, and Packaging testing. This role executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility, as well as Raw Material sampling and testing and sampling of clean rooms (as applicable).

Duties & 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 but not limited to 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
• Captures 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

Requirements

• 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.

Qualifications

• Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
• 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 technical knowledge in analytical methods
• Technical knowledge in analytical methods
• Strong focus on execution of non-routine analytical methods or processes
• Champions problem resolution
• Knows when to escalate to line management

Pay

The base salary range for this position is $75,000 to $122,000. 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.