SUMMARY OF RESPONSIBILITIES
This position is responsible for the operations associated with the filling and labeling of hematology, histology, immunology, and chemistry control products using various types of filling equipment as defined in departmental work instructions. This position is also responsible for performing other duties as assigned by management.
ESSENTIAL DUTIES AND FUNCTIONS
- Inspecting vials and caps for acceptability, racking vials, and placing tips and caps manually (if necessary).
- Torqueing vials to proper levels using various torque machines or in a manual method. Verify and document proper cap torque using a Torque Meter.
- Mixing and filling apparatus for daily operations. Filling vials with appropriate product by operating tabletop filling machines. Verify and fill vials with appropriate product. Document proper fill volume dispensing using volumetric & gravimetric methods.
- Pulling, identifying, storing and delivering appropriate samples and documentation throughout daily filling operations.
- Setting up, operating and making appropriate adjustments for filling machines.
- Complete labeling operations required within the fill department such as inspecting labels for proper printing of information and application of labels, racking and verifying vial counts.
- Verifying and signing for proper line clearance when initiating and completing each specific labeling operation.
- Maintaining control of product filling and labeling documentation for in-process products.
- Staging carts of product for labeling operations.
- Initiating complete documentation package for filling and labeling operations
- Maintain bacterial free work areas and proper clean room sterility using aseptic procedures including washing hands when entering and leaving the laboratory, and throughout daily operations.
- Report all problems, procedure or process issues, or personnel concerns to management.
- Comply with all departmental and company safety guidelines and regulations (including FDA and ISO regulations).
- Record component usage and labor hours to appropriate documentation or computer system.
- Other duties as assigned by management.
- High school diploma or GED education level required.
- Minimum of one-year previous experience operating machines in a manufacturing environment, preferably filling or packaging biological, medical or food related products.
- Must be dependable, well organized, possess good interpersonal skills, and be able to communicate effectively, both orally and in writing.
- Ability to perform general arithmetic.
- Accepting responsibility that results in anticipation/prevention of problem areas from actions, and problem solving inside and outside the department and organization.
- Takes responsibility for all work activities and personal actions.
- Recognizes the impact of one's behavior on others.
- Manages time and stays on schedule with deadlines.
- Knowing the (internal and external) customer business needs and acting accordingly; anticipating customer needs, and giving high priority to customer satisfaction and customer service.
- Responds to inquiries in a timely, service-oriented manner.
- Demonstrates a sense of urgency in serving a customer or product.
- Consistently delivers what the customers or team expect.
- Upholding generally accepted social and ethical standards in job-related activities and behaviors. Maintaining a positive attitude in the workplace.
- Recognizes company values and principles in daily work.
- Follows organizational policies, guidelines, and practices.
- Completes required compliance courses when due.
- Setting high standards regarding his/her work and working environment; developing quality standards, continuously evaluating performance, products, and procedures; actively seeking ways to improve quality.
- Demonstrates ability to provide quality work while following documents and procedures.
- Ability to complete tasks efficiently while always maintaining quality.
- Understands and promotes a commitment to quality.
- Establishes high standards, and exhibits collaborative, team focus in supporting overall team goals. Recognizes the importance of continuous learning and demonstrates appreciation for team and self-development. Takes opportunities to increase knowledge of relevant job skills for the betterment of the team. Provides cross training, instructions and constructive feedback to peers when appropriate and encourages team members and steps in to help in times of challenge.
- Collaborates with others on his/her immediate team to complete tasks.
- Recognizes areas of improvement in one's own work as well as how the team functions together.
- Seeks input from others when working towards common goals.
- Knowledge of and ability to operate various machines and devices such as: Unispense Machines, Filamatic Machine, Torque Machine, Accraply Labeling Machine, Avery Bench Top Label Machine, and more.
- Ability to manually tighten caps onto vials in a timely manner.
- Ability to visually inspect vials and caps for chips, breakage, size, liners and color and visually inspect labels for defects in printed information and improper placement on vials.
- Ability to count vials and maintain segregation of product by type, level, vial size, fill volume and specific label requirements.
- Ability to read and understand Safety Data Sheets (SDS) and the Employee-Right-To-Know program.
**WORK ENVIRONMENT/TRAVEL DEMANDS:
Position requires exposure to inside conditions. Protection from weather conditions, but not necessarily from temperature changes. Exposure to noise: there is sufficient noise to cause the worker to shout in order to be heard above the ambient noise level. Exposure to hazards: exposure to moving mechanical parts and chemicals. Exposure to atmospheric conditions: fumes, dusts, chemicals (Hydrochloric Acid, alcohol, acetone, bleach).
Travel demands for this position are estimated up to 0%. If travel is required, this travel may include customer visits, events/trade shows, and completion of presentations primarily throughout Domestic US or International regions. Employees must comply with all travel recommendations regarding “safe travel” according to company policies and guidelines, and all federal, state, local, and international orders.
Medium work exerting up to 40 pounds of force occasionally, and/or up to 20 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. This also includes standing, walking, pushing, pulling, lifting, reaching, stooping, fingering, grasping and moving the wrists, hands, and/or fingers. Expressing or exchanging ideas by means of the spoken word, receiving detailed information through oral communication and making fine discriminations in sound. Also has an expectation to make quick decisions, read and write, speak publicly, interpret data, problem solve, and be organized based on the work presented in order to retain job knowledge.
**The work environment characteristics and physical demands stated in their respective sections are representative of those necessary to perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.