Senior Records Management Coordinator

Company: CTI Education Group
Location: Fremont
Posted on: April 4, 2021

Job Description:

Job Description - Senior Records Management Coordinator (213466) 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. Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations. We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs. Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30+ biologics to market globally. Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future. Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients!-- # LI-MS1 *I-SF1 Description: Performs administrative activities related to Records and Information Management for BI Fremont with the following responsibilities:

• Responsible for administration and processing of records within the B4 High Density File room and other satellite file rooms on-site
• Provide inspection/audit support for retrieval and archival of records
• Performs annual audit of records within the file rooms and off-site
• Provide customer support for all information relating to Records and Information Management
• Ensures records are archived in accordance with local archival standards
• Provides support to other Quality Systems groups
• Document coordination in Idea for CON 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:
  • Control inventory and maintenance of GMP and non-GMP records within the B4 Vault and satellite on-site file rooms.
  • Ensure documents are filed properly and easily accessible
  • Manage retention period policy and document destruction
  • Support document scanning and off-site storage, including packaging, sending off, retrieval, and inventory of documents.
  • Verify that all previously checked out records have been returned and filed and or sent to offsite storage
  • Generate and maintain metrics for all records and specific record types
  • Support scanning and verification of life cycle documentation, including but not limited to executed batch records, final and raw material records, QC test records, executed validation records, and additional vital records as deemed necessary.
  • File scanned records to proper location in the B4 Vault.
  • Retrieve records to be scanned for various departments.
  • Support regulatory, client, and corporate audits/inspections as needed.
  • Ensure compliance with the BIFI records management program, acting as the point of contact for all department records related questions and issues. Participate in the annual record cleanup for the B4 Vault.
  • System Administrator for the Fremont LMS responsible for transacting training completions and requests for training program and assignment updates, as needed to support the training team.
  • Document coordinator for Idea for CON responsible for routine administrative tasks to support the creation, revision, and retirement of controlled documents, as needed to support the CDMS team. Requirements:
    • High School Diploma or GED with two (2) years closely related technical experience in Document Management, preferably in a pharmaceutical or chemicals manufacturing environment.
    • Associates Degree from an accredited institution with one (1) year of closely related Document Management experience, preferably in a pharmaceutical or chemicals manufacturing environment; OR a Bachelor's degree from an accredited institution, preferably in a science or engineering field.
    • Demonstrated ability to be organized and work well in small work groups.
    • Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
    • Detail oriented.
    • Demonstrated ability to read, comprehend, and follow written instructions.
    • Demonstrated written and verbal communication skills are required.
    • Must be able to work in a team environment.
    • Must be proficient in basic computer operations such as MS Office and Outlook and other computer based software
    • Highly regulated (FDA, DEA, EMEA, Virginia DEQ, and EPA).
    • May participate in BI interactions with various governmental agencies/regulators and external auditors.
    • Administer Document Operating Procedures and operate consistent with Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to Records Management.
    • Strong understanding and appreciation for regulatory requirements of Records Management standards under which the Fremont site is operating
    • Interacts with site to ensure consistency in Document Management policies and practices
    • Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
    • --Visual Demands - Eyestrain associated with the use of computer terminals and routine / repetitive work.
    • Temperaments/Mental Requirements - The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
    • Level of Proficiency - Experienced level subject matter proficiency required with technical expertise such that corrective actions resulting from procedural deviations are effective in a timely manner and that any changes to processes and procedures follow relevant change control procedures.
    • Attendance / Schedule - The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
    • To remain in this position, employees:
    • Must obtain & maintain qualifications, as required, to perform the assigned work.
    • Must understand, will be held accountable for and must adhere to all SOPs, company Policies and GMP requirements and Procedures
    • Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP's
    • Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time. Desired Skills, Experience and Abilities:
      • Preferred skills include experience in: Document Management Systems, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS) 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. 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; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

Keywords: CTI Education Group, Fremont , Senior Records Management Coordinator, Executive , Fremont, California