Description

　　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.

　　The Specialist, Production & Compliance will assist the production documentation teams with the batch documentation, procedural updates, deviations, change controls, CAPA's, Electronic Batch Records updates and document creation / revision in compliance with procedures and regulatory requirements. This role develops, reviews, and maintains an up-to-date training program to meet all compliance requirements and production requirements. The incumbent will ensure all personnel are up to date on all compliance requirements. The primary means of tracking training will be through LOS System. This role will be responsible to deploy and maintain the On-the-Job Training (OJT) program within the value stream.

　　The Specialist, Production & Compliance will be also responsible for the implementation and follow through of CAPAs to mitigate potential issues in deviations and audits and supports the deviation and change control processes. The incumbent should also support the creation and revision of Electronic Batch Records in the Manufacturing Execution Systems (MES).

　　This role will also have the responsibility to monitor inventory levels and purchase direct and indirect materials required to support production operations.

　　Duties & Responsibilities

　　Acts as production internal SME for routine production issues to support deviation management, product dispositions, and response corrections needed to continue production.

　　Develops and reviews written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures is required.

　　Works directly with upstream and downstream processes to ensure all documentation and procedures impacting the values stream are addressed to mitigate production downtime (this includes MES, Materials availability, among others).

　　Works directly with production leaders to ensure all shifts are working in compliance with production guidelines/specifications.

　　Assures the timely execution and completion of CAPA's, Investigations, Deviations, working in collaboration with Specialists, Supervisors, Local MSAT unit, Quality areas.

　　Works with Production Management to properly document any additional training needs such as Process Specifics, EHS requirements.

　　Performs all Company business in accordance with all regulations applicable to the site and Company policies and procedures.

　　Immediately reports noted/observed violations to management.

　　Responsible for maintaining the training curricula of production & PKG personnel to meet regulatory requirements.

　　Supports the overall production process and activities on a RFT (right the first time) basis.

　　Supports/authors the design, documentation, and implementation of Electronic Batch Records (EBR) within Manufacturing Execution Systems (MES).

　　Makes recommendations for continuous improvement to work processes and contributes to 5S program in work area.

　　Complies with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any safety and environmental events.

　　Supports and engages with the overall continuous improvement strategic initiatives by actively participating in all continuous improvement activities, ideas and change management processes.

　　Performs other job-related tasks and/or projects as required.

　　Requirements

　　Bachelor degree in Science, Business administration and/or a technical degree in sciences.

　　High School diploma with ten (10) years of related experience in lieu of education degree.

　　Two to four (2-4) years of relevant experience in manufacturing environment with knowledge in Qualification / Validation.

　　Minimum two (2) years of experience in a pharmaceutical industry and/or manufacturing environment or related field, with experience in cGMP documentation and training records.

　　Must have appropriate knowledge and good understanding of quality activities related to pharmaceutical manufacturing process; examples include product release, batch record review, root cause analysis, change control.

　　Must possess full fluency in MS Office (Word, Outlook, PowerPoint, MES).

　　Ability to document legible, precise and clear in documents, following good documentation practices and cGMPs.

　　Has good interpersonal relations and exhibits pro activity.

　　Proficient in Spanish (verbal and written) and basic knowledge in technical English.

　　(hear and/or read and understand instructions and technical documents).

　　Ability to perform math calculations: Sum, subtract, multiplication and division; rounding; percentages.

　　Good organizing skills when working with documents and reports.

　　Problem solving abilities.

　　Demonstrated skills in oral and written communications, independent judgment, teaching and training, problem solving/decision making, adhering to timelines, negotiation skills.

　　Demonstrated high ethical and professional standards with all business contacts to maintain BIAH excellent reputation in the community.

　　Must be service-minded, flexible, and possess strong interpersonal skills.

　　Capability to handle multiple conflicting tasks in a fast-paced environment is a must.

　　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.

　　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.