Hybrid or Onsite: 100% On Site
Work Schedule: Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
Summary/Overview of this role and Responsibilities:
1. Operates automatic and/or semi-automatic inspection equipment following all established cGMP’s and Safety regulation maintaining equipment's up time and running to reduce downtime to a minimum. Performed manual and semi-automated inspection for liquid and lyophilized products, including syringes.
2. Operates automatic and semi-automatic packaging equipment following all established cGMP’s and Safety regulation maintaining equipment's up time and running to reduce downtime to a minimum. Performed manual and semi-automated packaging and syringes combination products assembly process, when necessary.
3. Cleans all packaging/assembly/inspection lines according to procedures, as needed. (day to day)
4. Verifies components against the packaging process order.
5. Completes area accurate (error free) documentation required before line star up and during the packaging process, following good documentation practices and delivers it on time.
6. Performs housekeeping and handling of waste according to procedure.
7. Inspects the quality and accuracy of all data printed during the inspection/assembly/packaging processes.
8. Detects discrepancies during the packaging process, performs reworks/re-inspection as required by procedures.
9. Attends to all mandatory training meetings for cGMPs, EHS and company policies.
10. Participates in special projects and during audits and regulatory inspection and assists manufacturing activities in other areas within operations, as required.
Experience & Education Required:
High School Diploma
At least One (1) year of experience within pharmaceutical industry
Knowledge in operating the following inspection/assembling/packaging equipments:
a. Manual inspection booths, Semi-automated inspection equipment (e.g. V-90 Seidenader)
b. Labeler machines for Parenteral products
c. Cartoner machines
d. Check weigher and/or scales
e. Electronic equipment
f. Vision systems
g. Manual assembly/packaging lines
h. Secondary packaging semi-automated equipment
i. Combination product assembly equipments
Accurate visual inspection (e.g. products and components defects) - The use of contact lenses is not permitted in the work area (SOP QA- S-040)
Knowledgeable in CGMP practices, process area, documentation, safety, EHS and hygiene practices.
Good communication and Interpersonal skills
Basic knowledge on computerized system.
Good leadership and commitment
Ability to enter data into a computer and perform process transactions.
Ability to operate pallet jacks (manual)
Driver's License
Additional Requirements:
*The candidate must approve the sight screening test established within the Quality Assurance or Packaging Standard Operating
Procedure (SOP)
* No se permite en el área: CELULARES, uñas largas, uñas postizas, cualquier tipo de joyas, maquillaje, pestañas postizas, esmalte de uñas, crema de manos, medicamentos de ninguna clase, hebillas pequeñas de cabello, entre otros.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*