US_ Master QC Associate, QC Lab General

Boehringer Ingelheim•Fremont, CA

5d•Onsite

About The Position

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing. Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility. Execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable). SME in 3-5 analytical methodologies within different scientific principles. Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Coordinates routine maintained activities. Responsible for quality and compliance activities (authoring of non-routine test methods, specs, plans, reports, forms, SOPs) of moderate complexity. Performs duties under limited supervision and according to standard operating and QC procedures. Serves as QC subject matter expert (SME) representing the department during audits for core topics within group. Performs analytical testing for method transfer/validations/qualifications, verifications and technical assessments. May be responsible for one or more QC related compliance (deviations or OOS or CAPAs or CCs) deliverables for routine or core processes. Trains others as a SME. 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.

Requirements

High School Diploma with six (6) years’ experience of experience in cGMP regulated industry or equivalent.
Associate Degree with four (4) years’ experience of experience in cGMP regulated industry or equivalent.
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.
Bachelors degree from an accredited institution in a science or engineering related field, with four (4) years of experience in cGMP regulated industry or equivalent; Or Masters degree from an accredited institution in a science or engineering related field, with one (1) years of experience in cGMP regulated industry or equivalent.

Nice To Haves

Audit experience preferred.

Responsibilities

Executes independently with adequate training non-routine analytical testing methods.
SME in 3-5 analytical methodologies within different scientific principles.
Performs investigational testing and troubleshooting of analytical methods.
Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
Identifies and implements new improvements to lab processes compliance activities.
Responsible for quality and compliance activities (authoring of test methods, forms, SOPs) that are non-routine.
Manages and reviews fundamental tasks such as but not limited to: buffer prep, TCU maintenance, and cleaning.
Serves as QC subject matter expert (SME) representing the department during audits for core topics within group.
Performs analytical testing for method transfer/validations/qualifications, verifications and technical assessments.
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 improve 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.
Establishes training curricula and train others as a SME.
Supports OOX and OOE investigations.
Identifies protocol discrepancies and ensures they are properly defined, 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.
Ensures deviations assigned are promptly closed.
Responsible for training others.
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment.
Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance.
Proven experience with technical review, analysis and interpretation of scientific data.
Experience with computer-based systems and ideally experience with process control systems.
Previous experience authoring SOPs, methods, and/or work instructions and document work in a written format applying cGMP/GDP standards.
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.
Track record of troubleshooting and applying the scientific method to solve technical problems.
Strong written and verbal communication skills.
Ability to work as part of a high performing team and collaborate effectively with staff.
Clearly understand subject matter and concisely communicate within areas of subject matter expertise.
Audit experience preferred.
Strong technical knowledge in analytical methods.
Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues.