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Senior Associate, Quality Control

Company: Boehringer Ingelheim
Location: Fremont
Posted on: January 11, 2022

Job Description:

Job Description: Description: Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheims 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 Ingelheims 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 #PDN Description\: Responsible for providing analytical testing support by conducting cGMP assays for release, stability, validation, and in-process samples. Responsibilities include conducting analytical testing per approved SOPs and methods, analyzing and reporting data, and maintaining lab equipment. Report aberrant results to supervisor and assist in lab investigations as required. Generate new and/or revise analytical SOPs and methods. Maintain laboratory cleanliness and orderliness. Perform all lab operations in a safe and compliant manner. Identifies problems and generates alternatives and recommendations to resolve problems. Incumbent coordinates and conducts reviews and investigations in situations involving deviations of product quality from governing procedures, processes and regulations; assists with on-the-job training for junior-level staff and serves as a resource to them on technical or process questions. 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\: Analytical Testing\: Under minimal supervision, performs testing, conducts lab investigations, problem-solves, provides supervision of product testing and reports aberrant results to management. Under minimal supervision, performs required cell and/or reagents qualifications. Performs Quality Control Biochemistry Testing Group (eg., HPLC, CE, PCR, Bioassay, ELISA, and Physico-Chemical)in a timely manner. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner. Documentation\: Generates, reviews and/or maintains records or documents in a detailed and consistent manner. Ensure all equipment use logs are recorded for assays performed. Assists with QC's data management, including data review, assay monitoring (e.g., invalid test log and control chart log). Process improvement and compliance\: Coordinates and manages continuous improvement projects Revises standard operating procedures, training manuals, etc. which are submitted to management for adjustments and final approval. Maintains specific QC files and database records for process and/or quality improvement efforts. Actively support cross functional teams and share information, as appropriate, with colleagues. Effectively communicate with supervisors, colleagues and/or managers in other departments and sites. Participate in method validation and method transfer activities. Demonstrate troubleshooting and critical thinking skills. Highly productive, attention to detail, ability to manage own time and prioritize tasks independently to meet time lines. Maintain laboratory cleanliness and orderliness. Dispose expired chemicals timely, ensure all equipment is within calibration and/or qualification dates and resolve any malfunction issues through appropriate SOPs. Ensure that training is up-to-date and other personal development programs are in place. Requirements\: Bachelors degree in Biochemistry, Chemistry or Biology is required. Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels. Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals. Demonstrates strong attention to detail, and an ability to focus on details of execution. Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data. Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated technical expertise. Expertise is required in Bioassay and ELISA (ProA ELISA, CHOP ELISA, Gene Expression, Cell Proliferation, Binding ELISA, and Binding Activity). The required expertise is with respect to demonstrating theoretical understanding and providing effective analytical troubleshooting. Five (5) years experience with cGMP is required. Experience is required in conducting analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines. Experience in trending analytical data (method data and product data) is preferred. Direct experience is required in method qualification, method transfer, and method validation in accordance with ICH guidelines. Direct experience is desired in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems. Experience in method development is desired. Knowledge of and the ability to implement CFR, USP, and ICH requirements is desired. Knowledge of LIMS, ELISA software (i.e., Softmax Pro) and luminometer is required. Ability to implement and demonstrate testing in accordance 21CFR11 is required. Eligibility 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 here 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 persons 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 statu...

Keywords: Boehringer Ingelheim, Fremont , Senior Associate, Quality Control, Other , Fremont, California

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