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Senior QC Associate, QC Lab General

Company: Boehringer Ingelheim
Location: Fremont
Posted on: August 3, 2022

Job Description:

Description:Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations. - -We are continuing our rapid growth, investing over - $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs. - -Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of - years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30+ biologics to market globally.Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients! -#LI-MS1 *I-SF1 #PDN1Description\: 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.Duties & Responsibilities\:

  • Executes independently with adequate training 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.
  • 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.
  • 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 Requirements\:
    • Associate Degree with 4 years' experience of experience in cGMP regulated industry or equivalent OR - -Bachelors Degree from an accredited institution in a science or engineering related field.
    • 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.
    • 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 concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
    • Proven experience with technical review, analysis and interpretation of scientific data.
    • Strong written and verbal communication skills.
    • Ability to work as part of a high performing team and collaborate effectively with staff.
    • 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 issuesEligibility Requirements\:
      • Must be legally authorized to work in the United States without restriction.
      • Must be willing to take a drug test and post-offer physical (if required)
      • Must be 18 years of age or older
      • -This position will require individuals to be fully vaccinated against -COVID-19 -or have an approved medical or religious accommodation. Click - -for more information on the vaccine mandate and -COVID-19 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 - -and join us in our effort to make more health. -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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.RSRBI

Keywords: Boehringer Ingelheim, Fremont , Senior QC Associate, QC Lab General, Healthcare , Fremont, California

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