GMP Technician III, Athens

Company: Boehringer Ingelheim
Location: Nicholson
Posted on: August 6, 2022

Job Description:

Description:

Description:

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 Production personnel.

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.

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 final product.
• 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 performance improvements.
• 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/ packaging process.
• Performs special projects as required and/or assigned by Manager as well as participates in meetings associated with area of responsibility.
• 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 required.
• 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 degree.
  • 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 documentation practices.
  • Should have effective oral and writing communication skills.
  • 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 minimum supervision.
  • 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 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.
    • 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 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.
      
      

Keywords: Boehringer Ingelheim, Athens , GMP Technician III, Athens, Professions , Nicholson, Georgia