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 purpose of this position is for the coordination of documentation systems to ensure compliance, control, accountability, traceability, communication, retrieval and archiving of critical documentation throughout the lifecycle of the documents, including routing and issuance. The Associate III, Documentation will support maintenance of databases, accuracy and tracking of SOP's, Form revisions, Unusual occurrences, CAPA items, OOP revisions and shop packets. This position will also assist Production personnel with administrative activities such as preparation of batch records, filing of shop packets, release paperwork for antigen/seeds and other Production records as needed. This position will be responsible for all seed usage and paper trail requirements (including audits, inventories and OOP requirements).
Duties & Responsibilities:
- Prepares, routes and tracks revisions for SOP's and controlled forms.
- Monitors batch records for errors and applies improvements to those forms through revisions to reduce errors.
- Assembles folders with required batch records and support documents for each lot produced.
- Assembles folders for all cleaning documentation, autoclave runs, filter testing, bioreactor and tank logs.
- Prepares shop packets as needed and enters data into MAPICS after completion of process.
- Cross checks shop packets against batch records to reduce inventory errors and usage errors (compliance).
- Tracks and prepares supporting documentation for Unusual Occurrences and CAPA items.
- Accountability and transfer to QA archives of all monthly cleaning logs, equipment logs, filter integrity testing to ensure compliance with routine activities in Production.
- Maintains database for harvest results and provide trending reports.
- Compiles and transfers completed records, logs and seed records to Doc Center for storage and archiving.
- Ensures integrity of seed traceability documentation.
- Assembles and monitors progress of test reports for timely release of antigens.
- Assembles test reports and is a designee for release of batches.
- Responsible for the control of seed inventory and retrieval, archiving of cell culture and seed records for QQA review.
- Responsible for the compilation and tracking of OOP and registration changes/revisions.
Requirements:
- High School degree or GED.
- In addition to High School degree or GED, a minimum of two (2) years documentation experience in Pharmaceutical or Biological manufacturing environment, Business and Technical Competence, Communication, Delivering Results, Time Management, Initiative and Quality Mindset.
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.
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 is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. 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.