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Specialist, QC Raw Materials

Company: Boehringer Ingelheim Pharmaceuticals
Location: Fremont
Posted on: May 13, 2022

Job Description:

minutes of inactivity. Job Description - Specialist, QC Raw Materials (224737) 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. Specialist, QC Raw Materials - 224737 Description: Responsible for revising/creating raw material specifications and releasing raw materials for GMP use. Incumbent exercises judgment within well-defined and established procedures and practices to determine appropriate action on complex, non-routine projects; identifies problems and generates alternatives and recommendations within defined processes. Trains other staff, serves as a subject matter expert and may be a lead within the team. 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:

  • Create/updates raw material specifications and SOPs as required. Maintains RM released data lot packets and reports. Create RM final reports. Works with SQM and Quality Compliance on material qualification. Coordinates with SCM and Logistics the schedule for creation of new raw material specifications. Review raw material lot packets to ensure appropriate samples are taken and tested according to specification. Performs final disposition and release of raw materials in SAP. Be a "Super User" of the SAP system for disposition of Raw Materials.
  • Performs an Owner role for Change Controls and Deviations. Represents QCRM in cross functional meetings.
  • Documentation:
  • Independently writes and/or updates raw material specifications and reports.
  • Responsible for ensuring all raw material documentation and reports are reviewed and are in accordance with the raw material specifications.
  • Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
  • Prepares sample reconciliation reports, periodic trend reports, generate metrics and other reports as needed. Reviews and reconciles reports with internally produced data. Maintains raw material released data lot packets and reports, creates raw material final reports.
  • Process improvement and compliance:
  • Pro-actively reviews and develops new raw material specifications, standard operating procedures, protocols etc. to ensure BI stays at the forefront of quality control practices. Leads continuous improvement projects.
  • Enters data in databases as appropriate.
  • Performs an Owner role for Change Controls and Deviations.
  • Represents QCRM in cross functional meetings. Acts as a "Super User" of SAP system for disposition of raw materials.
  • Involved in training and on-boarding of all level QC employees and serves as a lead.
  • Represents Quality Control raw materials group in cross-functional meetings, shares subject matter expertise.
  • Leads continuous improvement projects and acts as Quality Control subject matter expert on continuous improvement projects. Requirements:
    • Requires a Bachelor's Degree in Biochemistry, Chemistry, Microbiology, Molecular and Cellular Biology, or Biology (or closely related degree with these core courses as the foundation)
    • Six (6) years of quality control experience in the pharmaceutical industry providing guidance to Manufacturing Operations, QA, and other cGMP areas.
    • Strong independent judgment and decision making abilities required.
    • Strong knowledge of relevant regulatory guidances.
    • Demonstrated problem-detection and problem-resolution skills required.
    • Strong conflict resolution and negotiation skills required.
    • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
    • Must possess excellent verbal and written communication skills
    • Knowledge of LIMS and Waters Empower Chromatography Data System is desired. -
    • Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned.
    • Visual Demands - Must be able to read and see clearly. -
    • Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct. - 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 Our Culture: Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Vetmedica Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer. Minority/Female/Protected Veteran/Person with a Disability Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. -

Keywords: Boehringer Ingelheim Pharmaceuticals, Fremont , Specialist, QC Raw Materials, Other , Fremont, California

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