Sr Specialist/Specialist Manufacturing Compliance, Fremont CA

Duties & Responsibilities

• Manages moderate to complex investigations, change control records, trending program and projects. Responsible for achieving deviation, change control and project goals including timelines and scope. Creates schedules and monitors the deliverables against the timeline.
• Develops strategies to reduce the turnaround time of deviations and change controls owned by self. Manages trending of one or more commercial product.
• Thoroughly investigates moderate to complex 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.
• Influences peers and cross functional groups to make decisions of limited scope, driving improvement of business processes.
• Responsible for maintaining inspection readiness within Manufacturing
• Independently analyze data relative to defined KPI. Implement recommendations for improvement based upon the data gathered
• Develops and provides hands-on training / guidance on MFG compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout MFG organization.
• Independently Initiates lean manufacturing techniques in order to actively reduce cycle times. Identifies moderate to complex projects for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.
• Coach and mentor junior level staff on small to medium investigations and change controls as needed. Mentor and support junior staff by providing guidance in decision making, determining strategy, authoring change controls. Provides support and guidance to other project team members.
• Performs the process monitoring /trending to evaluate trends and identify improvements.

Description

Individual contributor responsible to manage investigations, own change control records, create trending protocols/reports and lead projects in support of Manufacturing Operations. This position performs planning, monitoring and reporting of deviations, change controls and improvement projects. This position is responsible to own deviation investigations, change control records and trending protocols and reports. The Sr. Specialist will represent quality records during regulatory and customer audits. Accountable for continuous process improvements and efficiency gains. 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.

Sr Specialist Requirements

• Bachelors degree from an accredited institution, preferably in a science or engineering related field plus three (3) years of experience in cGMP pharmaceutical manufacturing environment with positions of progressive responsibility.
• Also acceptable: Associates Degree from an accredited institution plus six (6) years of experience or High School Diploma plus eight (8) years of experience as listed above.
• Significant experience leading meetings of various scope and size. This skill should be mastered.
• Projects are cross functional and the project scope is moderate. The Sr. Specialist should be able to independently influence peers and managers to achieve a common goal and overcome obstacles.
• Demonstrated ability in technical writing
• Time management: Mastery in multi-tasking
• Experience in biotech, pharmaceutical manufacturing or device manufacturing is a requirement. Preferably experience being a leader.
• Composure around management: Sr. Specialist must remain cool under pressure, have demonstrated confidence presenting to Sr. Management and have some experience presenting/speaking to auditors to defined program of limited scope (e.g. deviations, change control records, general operational procedures)
• Experience with writing deviations, managing change control process, creating trend reports and general knowledge on what aspects are important to include in quality system records of various complexi