Almac Group is currently seeking a Quality OJT Trainer/Lead Investigator for our Durham, NC location. The dual role of Quality On the Job Trainer (OJT) and Quality Lead Investigator will provide training to the Quality department (QA and QC), to include SOP training, on-the-job training, training in new systems or procedures, and tailored training materials across multiple sites. In addition this position will also ensure that Quality Incidents (QIs), Technical Queries (TQs) and resultant Corrective Actions and Preventative Actions (CAPAs) are initiated, addressed and closed out in a timely fashion to prevent the re-occurrence of incidents and ensure customer satisfaction.
Responsibilities include but are not limited to:
- Assist managers with the onboarding of new starts ensuring, for example, that all appropriate facility and system access has been granted, training in core SOPs has been successfully delivered and approved. Facilitate on-the-job training to both new and existing employees in Quality related activities pertinent to their roles. This extends to include training in the use of internal IS systems by Quality. Assess trainees through various levels of evaluation including questionnaires, tests, practical exercises and assess competency by checking tasks performed (as applicable). Provide feedback on progress to employees and line managers and highlight any potential concerns.
- Regularly evaluate and maintain the training curricula pertaining to Quality job roles within the department (as required). Review LMS training reports for all Quality personnel against the training curricula for each role. Identify and escalate concerns. Prepare educational materials in conjunction with the authors for new or revised Quality SOPs or to supplement /compliment SOPs or technical training in key Quality processes to include, for example, case study materials, highlighting the impact of what happens when things go wrong and the potential impact.
- Liaise with colleagues working in similar roles locally/globally (OJT and LI) and within HRD to identify and implement shared training initiatives for Quality personnel and assist with inter departmental induction training and rotations, where required.
- Receives and processes all potential Quality Incidents and Technical Queries notification requests via the QA Helpdesk. Solicits additional information when needed, categorizes the incident and assigns the appropriate investigator, Responsible Point Person, and Quality Point Person (in the event of a critical incident). If the incident relates to another site or division, follow the relevant SOP. Updates the Responsible Point Person in Orion if necessary based on changes to the investigation scope. Registers the incident within the Orion tracking system and ensures the relevant departments are notified.
- Provides guidance and acts as a ‘Quality Point Person’ regarding the direction or scope of an investigation. Applies investigation and problem solving skills while maintaining a positive attitude towards those departments involved and take minutes of relevant meetings. Reviews and approves QIs and TQs ensuring investigations are thorough, corrective and preventative actions are meaningful and appropriate to prevent re-occurrence. Ensures the report is written in a comprehensive, presentable and non-ambiguous manner. Updates Orion to indicate approval of the report (including revisions) and log details of any CAPA. Provides the Project or Distribution contact with the approved report to be forwarded to the customer for acceptance (as applicable).
- Oversees the overall performance of the CAPA system by monitoring and tracking the progress and ensuring they are completed in a timely fashion. Reviews CAPA close-out notifications and processes close-out after assuring responses are appropriate and fulfills the requirements set forth. Provides updates to customers regarding the status of CAPA (if required).
Required Experience / Education:
- Associates Degree with 1 year of relevant experience or, High School Diploma with 3 years of relevant experience
- A minimum of one year Quality or Quality Management
- GMP and Investigational Medicinal Products
- Ability to maximize efficiency through successful time management and the ability to prioritize daily activities independently.
- Ability to apply problem solving skills to a wide range of issues unsupervised and act in a QA advisory capacity.
- Collaborative - ability to work with teams, good interpersonal skills, good negotiation skills
- Customer service/client relations
- Communication proficiency
- Attention to detail
- Competent in the Microsoft Office packages, (excel, PowerPoint, etc.)
- Excellent written skills in English
- Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures
Preferred Experience / Education:
- Training Qualifications/Certification, (Train the Trainer)
- Bachelor’s Degree in related field
- 3 years working in a Quality department
- Writing SOPs and training materials
- 1-2 years of delivering training to new and experienced employees
- Technical understanding of packaging and distributions activities.
- Experience conducting investigations
What Almac Group can offer YOU!
- Full medical, vision & dental benefits the 1st of the month after start date
- 20 days of PTO to start plus 12 holidays per year
- Company paid long and short term disability along with life insurance
- 401k company match
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing almost 5,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.