Location: Barceloneta, PR

Responsibilities:

• Operates packaging equipment as per written procedures.
• Evaluates process data and performs product sampling and inspections as part of the packaging process and quality monitoring.
• Performs the loading and handling of printed components, product, and finished goods.
• Manages the product according to safety instructions provided in SOPs and/or lot documentation.
• Assists in the troubleshooting and maintenance of packaging equipment, including labeler, weight checker, scales, filling, and blistering machine, among others.
• Provides support to the mechanic in the reparation and maintenance of equipment according to specifications.
• Follows lock-out, tag-out procedures before intervening with equipment.
• Monitors process parameters to ensure that weight, temperature, pressure, humidity, or others are within limits and in accordance to requirements established in SOPs and lot documentation.
• Informs any deviation or potential deviation to the supervisor.
• Takes action as per procedures to avoid or minimize impact to the process or operations.
• Inspects packaging tools and utensils, maintaining them in good condition.
• Performs the cleaning and housekeeping of the packaging equipment and areas, major and minor cleaning, and uses the correct identification as per procedures.
• Keeps the areas cleaned and organized, including using the correct identification according to areas cleaning status.
• Removes printed material and product between lots and according to procedures to avoid mix-ups or contamination.
• Alerts the supervisor about any potential safety hazard or contamination risk.
• Documents packaging and cleaning steps as per SOPs, batch records and lot official forms, including inspection, sampling and process monitoring.
• Informs the packaging supervisor and group leader about situations or atypical, risky conditions in the packaging area.
• Complies with all the training required to perform the tasks, including SOPs, forms, guidelines, Safety and Environmental training.
• Provides support in the auditing of the packaging lot records and related documentation.
• Provides direct support in other quality related activities such as product inspection, product sampling, micro sampling applying aseptic techniques, and others.
• Assists technical personnel in equipment and process validation, including performing the required sampling according to approved instructions.
• Participates in continuous improvement initiatives related, but not limited, to cost reduction, process optimization, quality level improvement, output increase.
• Performs the accountability of materials and components at the end of the packaging process.
• Completes documentation accordingly, following good documentation practices, cGMPs and SOPs.
• Returns materials and allocates waste in the respective designated areas.
• Performs material transactions in the inventory system.
• Uses the personal protective equipment (PPE) required for the process or task to be performed.
• Uses the PPE in the right way, according to SOPs, Safety guidelines and training.
• Maintains the PPE in good conditions.
• Follows site general procedures and policies.

Requirements:

• High school diploma or Associate /Bachelor Degree is preferred.
• Experience in packaging process and equipment operation is highly preferred, including inspection of printed components and product.
• Knowledge and experience working in a GMP environment, with good documentation practices, as well as product sampling and inspection is highly desirable.,
• Availability to work ALL shifts, overtime, nights, weekends, and holidays as per business needs.
• Languages: English, Spanish

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $13.00/hr.