Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area. Support with troubleshooting to equipment.
Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine. This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage
Assists with the equipment changeover
Assists with minor equipment repairs/adjustments
Assists with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues
Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements
Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes logbooks, as required.
Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations
Movement of product and components within the assembly and packaging area
Transfer product, components and equipment within the CNC area.
Communication and hand-off to relief personnel during shift change as appropriate
Maintains production areas according to predefined standards (5s)
Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately
Skills:
Demonstrated ability to be organized and work well in small work groups.
Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
Demonstrated written and verbal communication skills are required.
Must be able to work in a team environment.
Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting
Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
Level of Proficiency - Entry level in subject matter
Attendance / Schedule - The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
To remain in this position, employees:
Must obtain & maintain qualifications, as required, to perform the assigned work.
Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP's
Education:
High School degree plus minimum one (1) year work experience in GMP regulated industry
Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred