Under general supervision, this position supports several areas of manufacturing compliance (New Product Introduction (NPI), deviation/Corrective and Preventative Actions (CAPA), change control, project management, trending key performance metrics, training, audits/inspections) in order to ensure manufacturing facilities are compliant with regulations, policies and procedures. This position works in close collaboration with the Quality and Manufacturing groups to perform such activities as investigating deviations, creating, implementing, and tracking CAPAs, implementing continuous improvement through change controls, and supporting the introduction of new products into manufacturing. This position is also responsible to contribute to the department by completing specific projects or activities to keep Manufacturing prepared for audits and inspections.
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:
- New Product Introduction:
- Supports the introduction of new product introduction activities and ensures procedural requirements are met.
- Leads team to complete assessments on time, determine deliverables prior to introduction, and own the over-arching change control. Ensures deliverables meet procedural requirements.
- Investigations and corrective actions:
- Thoroughly investigates deviation events utilizing root cause analysis techniques.
- Utilizes technical writing strategies to ensure content is clear, concise, and complete.
- Leads team to evaluate pertinent aspects involved in determining deviation scope, impact, and to perform necessary evaluations to support conclusions.
- Ensures corrections are initiated to address root cause and contributing causes discovered during investigation.
- Inspection Preparation and Readiness
- Participates in maintaining inspection readiness within Manufacturing.
- Generates play books for complex deviations, CAPA, and change controls.
- May identify, propose, and executes compliance process and procedural changes to reduce deviations.
- Implements corrective actions.
- Provides hands-on training / guidance on MFG compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout MFG organization.
- Leads area walk throughs for housekeeping
- Key Performance Indicators
- Under general supervision, analyze data relative to defined KPI. Make recommendations for improvement based upon the data gathered.
Requirements:
- Bachelors’ Degree with a focus in Biopharmaceuticals and/or Quality and/or > 2 years of professional experience or >6 years of professional training or equivalent.
- Broad technical knowledge of cGMP systems and experience with leading investigations, writing deviation reports, owning change controls, and corrective actions
- Understands manufacturing processes.
- Runs effective meetings.
- Skilled at creating and delivering presentations.
- Technical writing.
- Provides training and guidance to others.
Desired Experience, Skills and Abilities:
- Two (2) to four (4) years of professional experience.
- Experience with cross functional teams.
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
- 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 Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
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 background investigations and drug screenings.
Job
- Manufacturing/Production
Primary Location
- Americas-United States-California-FremontOrganization
- BI FremontSchedule
- Full-timePlease apply here.
Replies