Boehringer Ingelheim Associate, Quality Control in UNITED STATES, United States
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.
This is a mid-level staff Quality Control position, responsible for conducting analytical testing per approved SOPs, analyzing and reporting data, data review and maintaining lab equipment, for products that may include release, in-process and raw material samples. 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; assists with on-the-job training for junior-level staff.
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:
Under supervision, performs testing, conducts lab investigations, problem-solves, and reports aberrant results to management.
Performs wet chemistry, HPLC, Total Organic Carbon, conductivity and other compendial assays. Ensures testing and release time lines are met. Follows well-defined and established procedures and best practices.
Reviews QC test results
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, etc which are submitted to management for review 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.
Demonstrate troubleshooting and critical thinking skills.
Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet time lines.
Maintain laboratory cleanliness and orderliness.
Dispose expired chemicals timely, report any equipment malfunction, and report any equipment calibration past due.
Participate in method validation and method transfer activities
Interface with other functional groups within and outside QC to request/share information, provide results and coordinate testing.
Bachelors’ degree in Biology or Life Sciences required.
Demonstrates good knowledge of computer system validation, GMP and FDA, SUP and European regulations relating to material/product samples and testing.
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 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, with analysis/evaluation of data, using strong math skills.
Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated technical expertise.
Ensures compliance with and performs all company business in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives.
Physical Demands / Surroundings:
Lifting, carrying, pushing or pulling up to 50 pounds occasionally
Frequent periods of sitting, walking, and standing
Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
Occasional low level work, fine finger dexterity/ including grasping or pinching required
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.
Desired Experience, Skills and Abilities:
Two (2) to four (4) years’ experience in QC within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment, and with emphasis in aseptic processing, clean room operations, environmental monitoring, and/or validation and manufacturing processes.
Experience with LIMS or with off-the-shelf laboratory automation systems.
Experience in performing investigations related to biopharmaceutical quality issues is preferred.
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. 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. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Fremont
Title: Associate, Quality Control
Location: Americas-United States
Requisition ID: 187975