Works independently to provide quality assurance oversight activities of any area assigned of the business responsible for adhering to compliance with cGMP’s, regulatory, industry, and corporate requirements including critical utilities, (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, new product introduction/product transfer, external quality and laboratories . Demonstrates an excellent level of judgment and discretion in the timely identification and investigation and resolution of events impacting the Quality of products and processes. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, providing concurrence on corrective and preventive action plans (CAPA)/Deviation management, providing quality approval of impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet all requirements. Ensures Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
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 executing QA operations required to assess, evaluate, and review operations on the floor (as defined above) against cGMPs and to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business.
Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations. Authorized to suspend any operation when the situation warrants and immediately notify Quality Management. Provides guidance and control directives regarding remediation activities required to continue production. Is required to escalate critical issues within area assigned to senior management team based on severity of the issue.
Performs independent technical review of documentation during and post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings internally and to appropriate departments.
Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems. May attend project team meetings to provide QA guidance and oversight to such improvements.
May be asked to serve as a Subject Matter Expert for internal matters. Participates in inspection readiness activities and is involved in inspections by regulatory agencies.
* Bachelor’s degree, from an accredited institution, in Biology or Chemistry is preferred (or closely related degree with these core courses as the foundation) plus two (2) to four (4) years of Quality Assurance experience.
* In lieu of a Bachelor's Degree, High School Diploma with a minimum of six (6) to eight (8) years biopharmaceutical industry experience with cGMPs in areas described in this profile.
* Exercise independent judgment and decision making abilities required.
* Demonstrated knowledge of relevant regulations and guidances. (ie. cGMPs, SOPs, Protocols).
* Demonstrated problem-detection and problem-resolution skills required.
* Ability to facilitate conflict resolution and negotiation skills.
* 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; good interpersonal skills.
* 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. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.
* Visual Demands - Must be able to read and see clearly. Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color -blindness.
* 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.
* Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.
Desired Skills, Experience and Abilities:
* Bulk drug substance upstream and downstream purification operations experience strongly preferred
* Capability to establish good relationships with others who have different values, cultural styles and perspectives.
* Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.
* 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 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.