Boehringer Ingelheim Senior Quality Control Associate, QC Lab General in FREMONT, California
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
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). Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed. Coordinates routine maintained activities. Responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs). Performs duties under limited supervision and according to standard operating and QC procedures. Trains other associates and technicians on methods and processes.
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Executesindependently with adequate training 3-5 analytical testing methods withdifferent analytical principles under minimum oversight by qualified staff.
Manages and reviewsfundamental tasks such as but not limited to: buffer prep, TCU maintenance, andcleaning. Identifies and implementsfundamental improvements to lab processes compliance activities. Responsible for routine quality andcompliance activities (authoring of test methods, forms, SOPs).
Documents workaccording to cGMP and cGDP. Adheres to established regulations and follows cGMPestablished by site. Reports abnormalities and deviations in a timely andaccurate manner. Adheres to safety standards and identifies unsafe situations /habits and escalates appropriately. Maintains and improves lab areas accordingto predefined standards (5s).
Maintains owntraining within compliance and trains other technicians and associates onoperations upon completion of trainer qualification. Conducts group trainingson compliance topics and scientific principles as needed.
Coordinates workwithin the team and cross functionally.
Reviews data andidentifies discrepancies and ensures they are properly investigated, assessedand appropriate root causes are put in place.
Represents team inmatrix team meetings with cross functional team members to resolve issues andproduce solutions.
Trains otherassociates and technicians on methods and compliance.
Work performed in ahighly regulated (FDA, EMEA, MHRA, PMDA etc.) environment. Follow allapplicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance.
Bachelors Degree froman accredited institution in a science or engineering related field
Two (2) or moreyears of experience in cGMP regulated industry
Previous QCExperience preferred.
Experience withperforming analytical methodologies within different scientific principlesrelevant to Biopharmaceutical manufacturing
Ability to concentrateon detail oriented work in a complex technical setup with a Quality and Rightthe first time mindset.
Proven experiencewith technical review, analysis and interpretation of scientific data
Strong writtenand verbal communication skills.
Experience withcomputer-based systems and ideally experience with process control systems
Previous experienceto read and understand SOPs and/or methods and document work in a writtenformat applying cGMP/GDP standards.
Ability to work aspart of a high performing team and collaborate effectively with staff.
Strong technicalknowledge in analytical methods. Work independently with very littlesupervision, champions problem resolution, knows when to escalate to linemanagement, and provides compliant and smart solutions for moderately complexmethod and testing issues.
Must be legallyauthorized to work in the United States without restriction.
Must be willing totake a drug test and post-offer physical (if required)
Must be 18 years ofage or older
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.
Organization: US-BI Fremont
Title: Senior Quality Control Associate, QC Lab General
Requisition ID: 212311
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