SUMMARY / OBJECTIVE Under minimal supervision, this position is responsible for performance of clinical packaging operations including both manual activities (such as labelling and kitting) and the operation of automated and semi-automated equipment (such as bottling and blistering) in a GMP environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Assist in the development of new processes in procedures under the management direction including:
- Becoming subject matter expert for clinical packaging equipment.
- Assist in adapting equipment understanding into new SOPs and work instructions and assist in the training of additional staff on equipment specialty.
- Front line troubleshooting for processes and equipment.
- Perform Packaging Manufacturing activities including:
- Materials sampling, staging, dispensing, and return.
- Read understand batch records and work instructions.
- Packaging Equipment and Room set-up, operation, and cleaning.
- Use of appropriate personal safety equipment and engineering controls.
- Use Experic IT Platform.
- Support investigational and quality systems activities.
- Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
ADDITIONAL POSITION REQUIREMENTS
- Carries out duties in compliance with all federal and state regulations and guidelines.
- Complies with all company and site policies and procedures.
- Mechanical Aptitude, curiosity to explore complex machinery, and a desire to learn new processes.
- An ability to learn and remain self-directed on task that are both well-defined and more exploratory.
- Learn, become and remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement.
- learning new skills, procedures and processes.
- Is available for other duties as required.
- Is available for overtime as needed.
QUALIFICATIONS: EDUCATION and/or EXPERIENCE
Requires a High School Diploma or GED plus four (4) years of experience in clinical packaging operations or clinical packaging quality.
- Read, and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.
- Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.
- Identify simple and moderate problems related to job function.
- Deductive Reasoning ' Demonstrated experience applying general and complex rules to specific problems to produce answers that make sense.
- Inductive Reasoning ' Demonstrated experience applying a logical process in which multiple premises, all believed true or found true most of the time, are combined to obtain a specific conclusion (includes finding a relationship among seemingly unrelated events).
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Knowledge of cGMP.
- Experience with Clinical Packaging Operations preferred.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems.
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work individually in a self-directed manner with less than daily oversight.
- Ability to work with others in a team environment.
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
- The employee is occasionally required to sit and reach with hands and arms.
- The employee must be able to lift and/or move up to 50 pounds frequently.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- Travel will be required less than 10% of the time, domestic and international.