Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary
The Sr. Quality Specialist, Training provides support to the Quality Control Laboratory and ensures compliance with cGMP and company policies, procedures and specifications. Specifically, the Sr. Specialist will be responsible for independently overall administration, execution, management, and maintenance of the training system, the specific details of which are as follows:
Management, continual assessment and improvement of the training system and its compliance with cGMP.
Provide subject matter expert (SME) support as needed for regulatory inspections and site Quality / Compliance efforts
Training of laboratory staff and Training Coordinators on their roles and responsibilities in the training system
Training of Training System assets
Management, maintenance, and monitoring of training records, both electronically within ComplianceWire Learning Management System (LMS) as well as any paper-based records.
Reviewing and approving of quizzes prior to SOP promotion to training
Assisting with the administrative setup of training sessions
Facilitating and / or conducting cGMP training for the laboratory (e.g. annual refreshers, new hire orientation)
Conducting training with Certified Trainers including Train The Trainer
Compilation of Training metrics
Secondary responsibilities may include assisting other aspects within the Compliance Department such as product complaint handling, vendor management, internal audits, and management of 3rd party, regulatory, or corporate inspections. The ideal candidate for this position should be comfortable in a public speaking environment as well as working one-on-one with individuals as primary contact for training related issues.
Job Description
Scope of Authority
- span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Responsible for the overall administration of the site training system for both new and existing employees in the Generics Business.
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Training Program
Training System Administration:
- Serve as the site Business System Administrator (BSA) for the site training system.
- Serve as the site SME for the training system; present/explain the system during audits.
- Serve as the primary point of contact for all training-related items for the department training coordinators; secondary point of contact for Certified Trainers and Department Management.
- Manage Training records, both electronic and paper based.
- Manage and conduct Introductory and Annual cGMP training sessions.
- Conduct classroom training during new hire orientation, annual GMP and Certified Trainers certification courses.
- Creation, implementation, management and maintenance of On-the-Job training program.
- Administration of the Training Coordinator program.
100%
Training Compliance
ComplianceWire Administration:
- Train personnel on how to use the system.
- Creation and maintenance of training curriculum / roles.
- Creation of Training Items.
- Review and approve quizzes associated with SOPs.
- Review SOPs for clarity prior to promotion to training.
- May serve as Training Coordinator for Compliance and Quality Systems department.
- Author new or revise existing Compliance procedures (SOPs and Work Instructions) as needed.
- Subject matter expert for the training system.
- May develop a SOP training matrix and monitor training compliance against that program.
Process Improvement
- Actively identify opportunities and implement improvements to the training program (based on supervisors’ input, audit findings, current investigation trends, industry trends/practices, etc.).
Metrics
Owner of Training System Metrics:
- Develop and monitor appropriate metrics to ascertain the effectiveness of the training.
- Compile monthly and quarterly Training metrics for inclusion in QRB reports.
Department Support
May support/assist in other aspects within the Compliance Department such as:
- Complaint handling
- Vendor Management
- Internal Audits
- Coordination of Inspection Readiness logistic activities
- Regulatory inspection support (e.g. War Room support, runner, scribe)
Other
- Other responsibilities as required by the management.
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Bachelor’s degree in a science discipline (Chemistry, Biology, Biochemistry, or Microbiology preferred) with a minimum of 6 years’ experience in a GMP environment is required.
- Experience in employee training is required.
- Experience with administration of an electronic training management system strongly is desired.
Knowledge
Proficiency in a body of information required for the job
- e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Strong knowledge of the 21 CFR Part 210 and 211, GDP and GMP.
- Strong knowledge of FDA and GMP regulations.
- Thorough knowledge of Company SOPs applicable to job.
- In-depth knowledge of all applicable Instructional Design practices.
- Technical and quality background related to pharmaceuticals.
Skills
&
Abilities
- Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Excellent communication, writing and interpersonal skills.
- Multi-tasked, ability to work independently or with minimum supervision, efficient and effective.
- Computer literate in MS Office suite (Word, Excel, Power Point, etc.).
- Strong attention to detail.
- Able to work collaboratively with others.
- Excellent interpersonal skills.
- Customer focused.
- Influence management capability.
Physical Requirements
- Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Incumbents are subject to extended periods of sitting, standing and walking; use of hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch; talk or hear; looking at monitor, moderate noise levels. Work is performed in a cGMP environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
