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Master Associate/Specialist, QC LIMS

Company: CTI Education Group
Location: Fremont
Posted on: November 18, 2021

Job Description:

minutes of inactivity.. Job Description - Master Associate/Specialist, QC LIMS (2111337). 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.. Master Associate/Specialist, QC LIMS-2111337. 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 #PDN1. Description:. This position is responsible for maintaining LabWare LIMS at BI Fremont in support of Quality and Manufacturing and assisting with implementing enhancements or new systems. LabWare LIMS contains the core functionality, additional modules (i.e. Stability, Reagent, etc.), and key interfaces (i.e. Empower 3). This may include identifying and implementing business process improvements that will drive Fremont's business performance and Quality innovation. Incumbent provides Subject Matter Expert (SME) technical expertise on the following areas:. Provides a high level of independent judgment and discretion in the timely identification, investigation, and resolution of issues impacting Quality Control department. Quality Control oversight responsibilities include ensuring adherence to cGMP requirements, proper change control, corrective action and preventative action plans, impact assessments for changes to equipment and processes, risk management, ensure documentation and investigations meet BIFI and regulatory standards. Work with autonomy and authority. Leads and assists in implementing continuous improvement efforts as it relates to Quality Control activities. Fosters quality collaboration among QC and QA staff.. Ensures programs and processes are aligned with Corporate/Global BioPharm and maintained in accordance with cGMP/Quality/Compliance regulations.. 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:. Responsible for maintaining LabWare LIMS systems (QC, Stability, Environmental Monitoring) at BI Fremont. May assist with the implementation of enhancements or new systems. Engage network to ensure alignment with Corporate/Global BioPharma sites and operating units. May be a delegate for the process during internal/corporate client audits and health authority inspections.. Responsible for training site staff involved with the LIMS systems. May be the key point of contact when working with internal partners (E&T, Validation, QA) and external partners (vendors).. Assist and be a delegate for QC SME for Data Integrity initiatives, continuous improvements, and related activities.. Assist in cross-functional investigations or assessments in support of change controls, CAPA/investigations or other compliance activities as it relates to LIMS and LIMS management program.. Manage moderate to complex projects to ensure deliverables are met on time. Apply project management experience and concepts to when working within QC teams and cross functional teams.. Assist in validation activities as it relates to LIMS; may include development and validation of interfaces or new reports.. May develop validation protocols using a risk based approach that meets current regulatory requirements and industry practices, with oversight from the Validation and QA.. Participate in inspection preparation activities as needed. Able to present and defend GMP documentation and practices in an internal and external audit as needed.. Participate in discrepancy investigations and deviation investigations, as applicable. Master Associate Requirements:. Bachelor's Degree from an accredited institution in Biopharmaceuticals, Chemistry, or Biology (or closely related degree).. Requires two (2) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas.. In lieu of Bachelor's Degree, a High School Diploma plus six (6) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas will be considered.. Minimum of two (2) years LabWare LIMS experience (Development, Validation, Maintenance). Strong independent judgment and decision making abilities required.. Excellent technical writing, verbal communication skills, and good interpersonal skills.. Must have experience in the application of validation principles.. Experience in interpreting and relating Validation standards for implementation and review to functional areas.. Knowledge and experience with implementing 21 CFR Part 11 and Annex 11 compliant instruments and software.. Independent decision making capability and ability to think conceptually and understand impact of decisions critical; strong conflict resolution and negotiation skills.. Working knowledge of validation of new computer systems, changes to existing computer systems, and/or decommissioning computer systems; includes experience with system life cycle documents.. Completion of Labware LIMS Administration 1 and LIMS Administration 2. Participates in Data Integrity and continuous improvement initiatives (data mapping, gap assessments, remediation).. Participates or experience leading projects with history of achieving results.. Good working knowledge of relevant regulations and guidances required in order to act as a resource for colleagues. Including but not limited to 21 CFR Part 11 and Annex 11.. Project management experience with the ability to manage multiple projects against given time-lines is preferable.. Participates in technical projects with an interdisciplinary project team, from planning to realization and start up.. Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.. Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.. Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.. Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.. The incumbent is expected to work cross functionally to assist with gathering user requirements, perform risk assessments, critical decision making, work independently with supervision, and know when to escalate issues or problems for resolution, provide compliant solutions for instruments remain in a compliant, validated state.. Good understanding of validation principles in pharmaceutical / biopharmaceutical / medical device industries.. Specialist Requirements:. Bachelor's Degree from an accredited institution in Biopharmaceuticals, Chemistry, or Biology (or closely related degree).. Requires three (3) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas.. Minimum of three (3) years LabWare LIMS experience (Development, Validation, Maintenance). Strong independent judgment and decision making abilities required.. Excellent technical writing, verbal communication skills, and good interpersonal skills.. Experience in interpreting and relating Validation standards for implementation and review to functional areas.. Knowledge and experience with implementing 21 CFR Part 11 and Annex 11 compliant instruments and software.. Independent decision making capability and ability to think conceptually and understand impact of decisions critical; strong conflict resolution and negotiation skills. Good knowledge of validation of new computer systems, changes to existing computer systems, and/or decommissioning computer systems; includes experience with system life cycle documents.. Completion of Labware LIMS Administration 1 and LIMS Administration 2. Experience with Data Integrity and continuous improvement (data mapping, gap assessments, remediation).. Experience leading projects with history of achieving results and outstanding outcomes.. Good working knowledge and understanding cGMP regulatory requirements and guidances required in order to act as a resource for colleagues. Project management experience with the ability to manage multiple projects against given time-lines is preferable.. Provide support managing technical projects with an interdisciplinary project team, from planning to realization and start up.. Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.. Must have experience in the application of validation principles.. Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.. Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.. Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.. Expected to work cross functionally to gather user requirements, perform risk assessments, critical decision making, work independently with supervision, and know when to escalate issues or problems for resolution, provide compliant solutions for instruments remain in a compliant, validated state.. Good understanding of validation principles in pharmaceutical / biopharmaceutical / medical device industries.. 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.. 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.

Keywords: CTI Education Group, Fremont , Master Associate/Specialist, QC LIMS, Other , Fremont, California

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