Absorption Systems provides analytical support for gene and cell therapy products through every stage of development. Absorption Systems also provides non-clinical testing services to pharmaceutical and biotech companies to support research and development of drugs, biologics, and medical devices.
The Training Specialist is responsible for developing, implementing, coordinating and delivering effective training activities and programs as part of the Quality Training Program in a GLP/GMP regulated contract testing facility. This position will foster employee knowledge of job requirements to support proper execution of tasks.
This position also manages the company-wide GLP and GMP training programs to ensure employee knowledge and understanding of regulatory practices and requirements.
- Maintain and/or revise GMP and GLP training program initiatives to meet or exceed regulatory requirements as well as industry standards
- Work closely with Quality and Laboratory Operations to develop a robust training program to ensure employees are qualified to perform duties
- Design, develop and implement new interactive training activities/courses/modules
- Approve GMP and GLP related training curricula
- Deliver and/or coordinate training programs such as various core GLP or GMP training and compliance awareness programs
- Oversee CGMP and GLP New Hire Orientation and Onboarding Training Program for All Employees, contractors or temporary employees.
- Ensure employee training records are tracked and maintained appropriately in an inspection ready state
- Provide support during FDA and other regulatory inspections when training records are requested
- Develop metrics and reports to assess the health of the training program. Monitor and track metrics related to individual and departmental training. React to the metrics to ensure compliance with training program.
- Develop and implement tools to measure effectiveness of training programs
- Identify areas of improvement within the training program, make recommendations and implement actions
- Audit company-wide training records regularly
- Support day to day Quality Processes, as necessary
- Perform other duties as assigned
- Minimum of a Bachelor’s Degree in the Life Sciences, or equivalent combination of education and experience
- Five years of experience in a GMP environment, including knowledge and experience with biotechnology and pharmaceutical regulatory expectations
- Three years of training experience in a manufacturing and/or quality floor operations environment
- Must possess interpersonal skills that foster communications with employees to yield effective training
- A team player with excellent oral and communication skills with a capacity to engage audiences across all levels
- Superior knowledge of GLP and GMP regulations including 21 CFR Parts 11, 58, 210 and 211
- Prior laboratory experience in a regulated environment a plus
- Ability to prioritize and manage several tasks simultaneously
- Must be able to work under minimum supervision and in a team environment
Absorption Systems cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:
- Medical Insurance Plan with Employer Contribution
- Dental Insurance Plans with Employer Contribution
- Vision Insurance Plan with Employer Contribution
- Health Reimbursement Account – Funded by Employer
- Healthcare Flexible Spending Account
- Dependent Care Flexible Spending Account
- Employee Life Insurance – 100% Employer Paid
- Employee AD&D Insurance – 100% Employer Paid
- Voluntary Life/AD&D Insurance for Employee, Spouse & Child(ren)
- Short Term Disability – 100% Employer Paid
- Long Term Disability – 100% Employer Paid
- Profit Sharing Plan
About Absorption Systems
Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. Additionally, Absorption Systems goes deep into each of those areas, offering in vitro, in situand in vivomodels to assess the properties in question. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems’ commitment to innovation and is soon to be an industry assay standard for in vitrodrug interaction assessment. Absorption Systems has facilities in Exton, PA, San Diego, CA, and Boston, MA to serve customers throughout the world.
Alongside of our enthusiasm for science and research, we have a passion to see each and every one of our employees grow and succeed both personally and professionally. We encourage our employees to continually enhance their ability to contribute to the success of the organization and advance their careers. Absorption Systems is committed to creating an environment where individuals are encouraged to grow and work in collaboration with each other while being passionate about innovation. The professional culture of our organization is a goal oriented environment full of internally driven and motivated professionals. Our company is unique in the fact that there is freedom for autonomy to execute and the ability for each employee to grow in directions that align their individual aspirations with company growth.
Please visit http://www.absorption.com to learn more.