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Sr Specialist/Specialist, QC Microbiology, Fremont CA

Company: Boehringer Ingelheim Pharmaceuticals
Location: Fremont
Posted on: November 18, 2022

Job Description:

Job Description - Sr Specialist/Specialist, QC Microbiology, Fremont CA (2212210) 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. Sr Specialist/Specialist, QC Microbiology, Fremont CA - 2212210 Description: - This is a high-level staff Quality Control position, responsible for conducting microbial reporting and investigation requiring a higher level of expertise than the Senior Associate level. Incumbent exercises judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations to resolve problems within defined guidelines. Incumbent coordinates and conducts reviews and investigations in situations involving deviations of product quality from governing procedures, processes, and regulations. Incumbent is also responsible for reporting, reviewing and approving test results, trend reports and validation of methods. Incumbent leads coordination and communication between departments and across functions. This role provides necessary planning, strategy, management, guidance, scientific justification, interpretation, determination of acceptability of data to the FDA, EMA and / or clients. This role has high impact on site performance in terms of compliance and client projects within multiple departments at the site. This position is responsible for implementing strategic plans for QC. The position is highly visible and critical to get BI products, developed and manufactured in Fremont, approved without delays to the project plans. Ability to manage projects and influence others. 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 several 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:

  • Microbial Reporting and Investigations:
    • Under minimal supervision, conducts lab investigations, problem-solving, provides supervision of microbial sampling/testing and reports aberrant results to management.
    • Follows well-defined and established procedures and best practices.
    • Reviews QC test results.
    • Documentation:
      • Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
      • Prepares sample reconciliation reports and other reports as needed.
      • Assists with QC's data management, including data review and control charting.
      • Process improvement and compliance:
        • Coordinates and manages continuous improvement projects.
        • Revises standard operating procedures, training manuals, business processes, and controlled documents which are submitted to superiors for adjustments and final approval.
        • Maintains specific QC files and database records for process and/or quality improvement efforts.
        • Manages and maintains Deviation and Change Control records.
        • Interface with other functions and departments:
          • Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
          • Assists manufacturing area managers or designates with areas identified for troubleshooting, for corrective actions related to quality investigations.
          • Provides technical expertise.
          • Executes established policies and supervises documentation of Test Methods and Specifications.
          • Ensures updates are performed on time and documentation meets current regulatory guidelines.
          • Performs all work in accordance with acceptable laboratory practice and regulatory criteria.
          • Champions problem resolution.
          • Leads OOX and OOE investigations.
          • Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place.
          • Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
          • Influences and leads inter-departmental meetings with cross functional team members to resolve issues and produce solutions.
          • Manages deviation investigations as applicable and provides product quality impact assessment.
          • Ensures deviations assigned are promptly closed.
          • Responsible for training others. Requirements: -
            • MS/MA, with 2 years' work experience in a GMP regulated industry (preferred). OR -
              • BS/BA with at least 4 years of experience in a GMP regulated industry.
              • Industry experience demonstrating good knowledge of computer system validation, GMP and FDA, SUP and European regulations relating to material/product samples and testing.
              • Working knowledge of quality monitoring requirements and testing methods.
              • Ability to present data, investigations, and laboratory processes to a larger audience (i.e., Upper management, regulatory agencies, clients etc.).
              • Ability to author protocols, test methods, and SOPs.
              • 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.
              • Track record of troubleshooting and applying the scientific method to solve technical problems.
              • Capability in conducting in-depth, complex investigations including an ability to articulate the investigation clearly in writing for submission to the Quality Control group.
              • Experience with computer-based systems and ideally experience with process control systems.
              • Previous experience authoring SOPs, methods, and/or work instructions.
              • Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.)
              • Ability to work as part of a high performing team and collaborate effectively with staff.
              • Experience interacting with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise.
              • Experience troubleshooting technical problems and/or equipment.
              • Demonstrates ability to lead projects of low complexity.
              • Demonstrates proficient computer skills (i.e., documentation systems, databases, and spreadsheets) and knowledge of Microsoft applications.
              • 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 strong attention to detail, and an ability to focus on details of execution.
              • Demonstrates ability to work effectively on problems of a diverse scope, with analysis/evaluation of data, using strong math skills.
              • Demonstrates good facilitation, organizational and problem-solving skills, as well as demonstrated technical expertise.
              • Knows when to escalate to upper management and provides compliant and smart solutions for complex validation issues.
              • Expert understanding of analytical methods and validation principles in pharmaceutical / biopharmaceutical / medical device industries.
              • Ability to work independently with very little supervision.
              • Physical Demands / Surroundings:
                • Writing and use of a computer keyboard frequently.
                • Occasional use of personal protective equipment.
                • Visual / Hearing Demands: Color vision and depth perception required.
                • May require extended hours at a computer screen.
                • Must be able to read electronic documents of all types.
                • Hearing acuity required. May be required to travel nationally. Sr Specialist Requirements:
                  • Bachelors degree in a science or engineering related field.
                  • Masters degree or PhD (preferred)in a science or engineering related field. -
                  • BS/BA with 6 yrs work experience in analytical testing in a GMP regulated industry.
                  • Masters degree with 4 yrs work experience in analytical testing in a GMP regulated industry.
                  • PhD with 2 years of work experience in analytical testing in a GMP regulated industry (or equivalent).
                  • Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.
                  • 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
                  • Track record of troubleshooting and applying the scientific method to solve technical problems
                  • Experience with computer-based systems and ideally experience with process control systems
                  • Previous experience authoring SOPs, methods, and/or work instructions.
                  • Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.)
                  • Ability to work as part of a high performing team and collaborate effectively with staff.
                  • Ability to interact with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise.
                  • Proven capability to independently solve complex technical problems.
                  • Demonstrated ability to lead cross functional projects of moderate complexity.
                  • Proven track record to mentor, train and lead others within discipline.
                  • Experience providing oral and poster presentations on complex technical problems to other scientific experts. - 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: Boehringer Ingelheim Pharmaceuticals, Fremont , Sr Specialist/Specialist, QC Microbiology, Fremont CA, Other , Fremont, California

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