GMP Technician III, Athens
Company: Boehringer Ingelheim
Posted on: August 6, 2022
The GMP technician is responsible for performing the audit of all
related Batch Sheets/Records and forms executed during the
Manufacturing or Packaging process. This role provides support to
documentation areas (Manufacturing/Packaging) by providing good
documentation practices and cGMPs know-how and support to the
functional areas, including support to special activities related
to quality at the shopfloor.
The incumbent monitors established controls to certify the active
pharmaceutical ingredient and/or drug products quality are in place
in the Manufacturing & Packaging Operations. This role provides
follow-up to production personnel to promote compliance and
adherence to SOP's, in accordance with current Good Manufacturing
Practices, based upon his/her findings during documentation audit.
This roll will receive general guidance from the
Manufacturing/Packaging Specialists, Auditors and Supervisors, but
handles routine matters independently. The incumbent provides
support on compliance and regulatory aspects to other QO and
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
Duties & Responsibilities:
- Audits the manufacturing, formulation, filling and/or packaging
process documentation (batch records, forms, checklists) to assure
adherence to cGMP s, Company Policies, and procedures.
- Provides documented evidence to support the disposition of the
- Responsible for the identification of scientific and
technological opportunities in manufacturing and/or packaging areas
for quality improvements.
- Analyzes data, recommends, designs, and implements process
- Responsible for continuous process verification activities
within the department for in line products (i.e., Risk Assessments,
Process Specific Trainings).
- Acts as Proactive Process Analysis owner for Operations.
- Evaluates and gives follow-up to all process deviations and
recommends further actions, and provides support in the
investigation of deviations, following the Deviation Systems and
OOS Investigations by means of the SAP System.
- Provides support to regulatory and compliance issues, like
complaint investigations, annual review preparation, supplier's
audits, etc. (as required)
- Responsible for obtaining and publishing QA metrics
(Documentation Errors) according to the schedule.
- Responsible for the collection of documentation performance and
product quality related data (yield) through the manufacturing/
- Performs special projects as required and/or assigned by
Manager as well as participates in meetings associated with area of
- Provides support in the training process to new auditors on
departmental practices and procedures.
- Acts as key user for Production Execution (PE) in the ERP, if
- Complies with all safety and environmental guidelines,
procedures, training, practices, permit conditions, and internal
notifications of any environmental and or safety events.
- Performs additional tasks as assigned. Requirements:
- High School Diploma, preferably associate degree, or technical
- Minimum two (2) years of experience in Pharmaceutical Industry
and/or Manufacturing Environment or related field.
- Strong understanding of cGMP's / EMEA and experience working
with a FDA, USDA, and/or any other regulatory agency.
- Ability to train people especially in SOPs, process tasks, good
- Should have effective oral and writing communication
- Problem solving skills applicable to cGMP documentation.
- Knowledge on basic mathematical operations (sum, subtract,
multiply, divide, percentage, fraction).
- Experience in analytical procedures, instrumentations,
manufacturing practices and procedures is highly preferred.
- Ability to audit documents and identify errors or wrong
entries/calculations, procedures is highly preferred.
- Excellent communication and interpersonal skills.
- Self-starter and ability to handle multiple priorities with a
- Ability to instill confidence.
- Knowledge of basic computer software: Word, Excel, Power Point,
and other if desirable.
- Knowledge in quality software and SAP desirable. Eligibility
- Must be legally authorized to work in the United States without
- Must be willing to take a drug test and post-offer physical (if
- Must be 18 years of age or older.
- This position will require individuals to be fully vaccinated
against COVID-19 or have an approved medical or religious
accommodation. Click here for more information on the vaccine
mandate and COVID-19. 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 and join us in our effort to make more
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.
Keywords: Boehringer Ingelheim, Athens , GMP Technician III, Athens, Professions , Nicholson, Georgia
Didn't find what you're looking for? Search again!