Responsible and accountable for supporting and managing document control activities including but not limited to: logbook management, cGMP document archival, batch record issuance, training management system, and document coordinator activities. Subject matter expert for related technical and compliance information within the Quality unit.
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:
- Manage and file all controlled GMP documentation in compliance with internal procedures and policies, as well as, regulatory requirements. Establishes and is accountable for maintaining the archival, retrieval, retention and destruction of controlled documentation.
- Responsible for the issuance, archiving and control of Log Books and/or laboratory notebooks for use in production.
- Issue batch records containing written procedures for production and process control.
- Assist with inspection readiness and preparation activities as required by management. As needed, audit preparation for regulatory agency audits/customer inspections.
- Identify Quality System process initiatives for optimization and compliance. Lead and execute improvement plans within area of responsibility.
- Resolves issues found during documentation review (documentation errors, missing information) as directed by SOP.
- Assists QA management with the development of training plans within department and trains others.
- Adheres to compliance and regulatory requirements.
- Bachelor's degree from an accredited institution and a minimum of two (2) years QA document control and/or quality systems experience in a GMP or similar manufacturing environment. Experience must be inclusive of at least one (1) year leading projects with a history of achieving positive results and outcomes.
- Demonstrated written and verbal communication, organization and teamwork skills.
- Sound decision making skills along with ability to take quick actions.
- Excellent attention to detail with an ability to be self-directed while managing projects and assigned accountabilities.
- Ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.
- Influencing the understanding of GMP's, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality.
- Shares technical and compliance knowledge horizontally and vertically across the site.
- High level of demonstrated technical competence, communication, integrity/ethics and analytical thinking.
- Demonstrates high ethical and professional standards with all business contacts in order to maintain the site's excellent reputation in the community.
- 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
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico 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 applicable law.