Senior Associate, Quality Systems - Change Management

Job description

Under general supervision, the Senior Associate, Quality Systems - Change Management routinely performs administrative tasks to support the creation, revision, and retirement of controlled documents according to Standard Operating Procedures to support current Good Manufacturing Practices operations. Incumbent is also responsible for support of the IDEA for CON System for BI Fremont. This includes but is not limited to providing 2nd level business support and issue resolution, facilitating the definition of user requirements, documentation and configuration, delivering workshops with/for Key Users, and preparing validation/testing documentation. Incumbent participates in a global cross-functional team of IDEA for CON LBA's, and provides coordinator training as needed for Doc Coordinator system usage. Incumbent also supports the management and audit of vital records and electronic records, and provides records management system support to record owners.

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.

Job Profile

Duties & Responsibilities

Controlled document management:
· Manages controlled documents for the Fremont site, to ensure correct implementation, access, and upkeep of documents.
· Acts as key point of contact for author and record users, and provides customer support and simple troubleshooting for creation and editing of documents.
· Distributes document links to the appropriate viewers.
· Informs users on the best ways to use the system; directs users to additional help, training courses and e-learning.
· Provides local business administrators with information about the appropriate roles for document signatories.
· System Local Business Administrator for Fremont IDEA for CON system, coordinates various levels of access to IDEA for CON for employees and external resources.
· Documenting the required configuration according to global standards, configuring the application according to specification and, where appropriate, testing the configuration prior to use in Production.
· Participating in regularly scheduled international user-based teleconferences and face to face meetings. Meeting regularly with user community representatives (one-on-one and in groups) to identify particular problem areas and determine solutions.
· Provides input into content on the IDEA for CON system. Also responsible for technical actions required to make local configuration support current business needs for document management.
· Administers and processes records within the B4 High Density Fileroom.
· Provides inspection/audit support for retrieval and archive of records; performs annual audit of records within the file room; provides customer support for all information relating to records and information management; and ensures records are archived in accordance with local archival standards

Requirements

· Three (3) to five (5) years of experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience
· Or a Bachelor's degree from an accredited institution and two (2) years' experience in business area (for example, engineering support or laboratory support) for responsible training function.
· Knowledge of where to go within the organization for required information, and ability to judge what information should be passed on to different levels of management or organizational units.
· Demonstrated analytical skills and a systematic approach to problem-solving, with an emphasis on process development and optimization, not just system maintenance.
· Demonstrated ability to deliver solutions in a timely fashion under rapidly changing conditions.
· Proficiency with DMS software and MS Office Suite, use of styles, formatting tools, transferring content from document to document; and an expert Word 2007 user.
· Excellent communication skills, both verbal and written.
· Physical Demands / Surroundings:
· Lifting and/or carrying <25 pounds occasionally; pushing and pulling <50 pounds occasionally
· May require frequent periods of sitting, walking, and standing.
· Climb stairs and ladders occasionally.
· Crouching/squatting, bending/stooping, twisting, above the shoulder or low level work, fine finger dexterity/ including grasping or pinching required occasionally.
· Writing constantly.
· Occasional periods of use of Personal Protective Equipment.
· Visual/ Hearing Demands: Color vision and depth perception required. May require extended hours at a computer screen. Must be able to read electronic documents of all types. Hearing acuity required.
· May be required to travel nationally.

· Must be legally authorized to work in the United States without restriction.
· Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
· Must be willing to take a drug test and post-offer physical (if required)
· Must be 18 years of age or older