Job Description:
We are seeking an experienced Quality Control Trainer to lead the development and delivery of comprehensive training programs for laboratory personnel. This role is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) and industry best practices within the quality control function.
The successful candidate will be responsible for designing, delivering, and evaluating training programs that meet all job requirements of laboratory personnel. Additionally, they will champion all training activities within the quality control function, maintaining and complying with laboratory documentation and computerized systems data integrity requirements.
Key Responsibilities:
* Design and deliver effective training programs to meet all job requirements of laboratory personnel.
* Champion all Training activities within the Quality Control function.
* Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
* Understand Regulations and business processes required to maintain Laboratory Data Integrity.
* Design and delivery of Onboarding program for new laboratory personnel to be team-ready within 4 weeks of start date.
* Delivery of Site quality training programs including GMP, Good Documentation Practice, and Quality Induction.
* SME on all Laboratory Equipment and procedures.
* Development of annual training plan based on laboratory training needs identified; ensure timely implementation of this plan.
* Introduce Comprehensive Competency-Based Assessment tools to all Instructor-Led training programs within the laboratory.
* Responsible for review and update of all analytical procedures required to support Analyst training needs.
* Work with management/leadership group to develop solutions that enhance individual and team training, leveraging IT systems, web-based applications, and Computer-Based Training.
* Leverage e-learning and blend different learning approaches.
* Manage, maintain, and update an efficient electronic training management system.
* Provide monthly training matrices, KPIs, and ComplianceWire reports as required.
* Measure and continually improve effectiveness of training in the journey to become best-in-class.
* Keep informed of best practices within the industry regarding Laboratory Training and work to implement best practices on site.
* Liaise with other AbbVie facilities to ensure consistent training approaches on similar activities across different sites.
* Ensure all safety aspects of the role are adhered to.
* Identify potential safety hazards in the laboratory and liaise with Lab Manager and EHS Officer to resolve.
* Lead and drive Compliance and GMP projects in the laboratory.
Requirements:
* A third-level qualification in Chemistry or related Science, preferably a Bachelor's Degree.
* Train-the-Trainer Qualifications an advantage.
* Minimum 4 years relevant Quality Control experience or equivalent combination of education and experience.
* Experience in pharmaceutical manufacturing facility.
* Demonstrate knowledge of cGMP requirements and practices, including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
* Previous experience in a pharmaceutical manufacturing environment in the design and delivery of comprehensive training programs an advantage.
* Demonstrate competency in the operation, calibration, and qualification of common analytical instrumentation, e.g., HPLC, Dissolution, GC, FTIR, Electrochemistry (DME), UV/Vis, and other USP instrumental and Wet Chemistry technologies used in pharmaceutical Quality Control Laboratory.
* Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.
* Demonstrated success in making effective and persuasive presentations on complex topics to upper management.
* Good organizational and interpersonal skills required.
About Us:
This organization values diversity and promotes equal opportunities for all employees.