Location: Barceloneta, PR Pay Rate: $13.00 / Hourly Schedule: 8 hours per day, 40 per week, 5 days a week. Availability to work non-standard shifts, rotating shifts, weekends and holidays when necessary.
Position Summary Responsible for operating packaging equipment according to approved procedures and ensuring that packaging processes are performed safely, efficiently, and in compliance with SOPs, cGMPs, batch records, and applicable quality and safety requirements.The position performs product and process inspections, sampling, equipment cleaning and monitoring, material handling, documentation, and inventory transactions. The employee also supports troubleshooting, equipment maintenance, audits, validations, investigations, and continuous improvement initiatives.
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.
Education/Qualifications:
High school diploma. Associate or Bachelor degree, is preferred.
English comprehension (reading/writing).
Collaborates in investigations on process deviations for the packaging area.
Provides support in the implementation of corrective and preventive actions (CAPAs).
Informs Health Services about any medical condition that could impact the performance of his/her tasks, others and/or the product being packed.
Alerts and informs the supervisor and group leader about any incident that could represent a risk or hazard for anyone or for the packaging process. Notifies immediately any accident or safety/environmental incident to the supervisor.
Complies with SOPs, training, guidelines, practices, permit’s conditions, event internal notifications as required.
Documents shift events and status in logs, as needed.
Segregates waste (dangerous, non-dangerous) according to procedures and guidelines. Performs environmental inspections to the waste area as required.
Able to perform math calculations: sum, subtract, multiplication and division; percentage; rounding
Able to monitor and measure time in hours and minutes. Able to perform calculations considering different times.
Availability to work non-standard shifts, rotating shifts, weekends and holidays when necessary.
Applicant Notices & Disclaimers
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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.The pay rate for this position is $13.00/hr.
