Senior Records Management Coordinator
Company: CTI Education Group
Posted on: April 4, 2021
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
- Responsible for administration and processing of records within
the B4 High Density File room and other satellite file rooms
- Provide inspection/audit support for retrieval and archival of
- Performs annual audit of records within the file rooms and
- Provide customer support for all information relating to
Records and Information Management
- Ensures records are archived in accordance with local archival
- 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 &
- 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
- 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
- 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
- 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
- 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
- Demonstrated mathematical skills, including the ability to
perform addition, subtraction, multiplication, division, and
- Detail oriented.
- Demonstrated ability to read, comprehend, and follow written
- Demonstrated written and verbal communication skills are
- 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
- 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
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