The posting
Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Flexible hours/shifts based on business needs
Position Overview
We are seeking an Inspection & Packaging Operator I to perform pharmaceutical product inspection and packaging activities within a regulated pharmaceutical manufacturing environment. The selected candidate will be responsible for executing manual, semi-automated, and automated visual inspection activities, as well as packaging operations, in accordance with approved procedures, batch records, cGMP requirements, and established safety standards. Responsibilities include identifying and classifying product defects, operating inspection and packaging equipment, verifying packaging components and materials, completing manufacturing documentation, and maintaining product traceability throughout assigned operations.
Required Qualifications
- High school diploma or GED required; additional technical education or pharmaceutical manufacturing training preferred.
- Previous experience in pharmaceutical manufacturing, visual inspection, packaging, or other regulated manufacturing environments preferred.
- Basic knowledge of cGMP requirements and Good Documentation Practices.
- Ability to read, understand, and execute approved Standard Operating Procedures (SOPs), batch records, and manufacturing instructions.
- Ability to identify and classify product defects in accordance with established inspection criteria following appropriate training.
- Ability to operate pharmaceutical inspection and packaging equipment after successful qualification.
- Basic computer skills and ability to use electronic manufacturing systems and equipment interfaces.
- Strong attention to detail and ability to identify product, material, equipment, and documentation discrepancies.
- Ability to accurately complete manufacturing records and maintain product traceability.
- Strong organizational skills and ability to follow standardized processes.
- Effective communication and teamwork skills.
- Ability to work in a fast-paced pharmaceutical manufacturing environment.
Preferred Qualifications
- Previous experience with visual inspection of injectable or parenteral pharmaceutical products.
- Experience with manual, semi-automated, or automated visual inspection equipment.
- Experience in pharmaceutical packaging operations and packaging line equipment.
- Familiarity with defect identification, classification, and inspection procedures.
- Experience working with electronic batch records (EBR) or Manufacturing Execution Systems (MES).
- Knowledge of material reconciliation, line clearance, and packaging component verification.
- Experience supporting GMP audits, investigations, and manufacturing quality initiatives.
- Familiarity with pharmaceutical manufacturing documentation and traceability requirements.
Key Responsibilities
Inspection Operations
- Perform visual inspection of pharmaceutical products, including parenteral products, using manual, semi-automated, or automated inspection processes.
- Identify, detect, and classify product defects in accordance with approved inspection procedures and established defect categories.
- Operate assigned inspection equipment and associated computerized systems following required training and qualification.
- Perform inspection activities according to established sampling requirements, inspection times, equipment challenges, and operational procedures.
- Segregate accepted and rejected units and maintain accurate inspection and reconciliation records.
- Verify product quality and report any abnormal conditions, visible defects, or discrepancies to appropriate personnel.
- Follow established procedures for handling inspected products, samples, rejected units, and manufacturing materials.
Packaging Operations and Documentation
- Execute pharmaceutical packaging activities in accordance with approved Standard Operating Procedures (SOPs), batch records, and work instructions.
- Perform packaging line setup, line clearance, equipment preparation, and in-process verification activities.
- Verify product identification, packaging components, printed materials, lot numbers, and material status before use.
- Operate assigned packaging equipment and computerized interfaces after successful training and qualification.
- Perform packaging activities, including product handling, labeling, inspection, and packaging component reconciliation, as applicable.
- Complete batch records, logbooks, and other GMP documentation accurately, legibly, and contemporaneously.
- Ensure proper identification, handling, and traceability of products, materials, and packaging components throughout the process.
- Maintain compliance with Good Documentation Practices (GDP) and applicable cGMP requirements.
Quality and Operational Support
- Participate in required GMP training, equipment qualification, and task-specific certification activities.
- Support deviation investigations, internal audits, regulatory inspections, and quality improvement initiatives as assigned.
- Assist with process validation, equipment qualification, and operational verification activities when required.
- Immediately report product defects, equipment malfunctions, material discrepancies, documentation errors, and potential quality or safety concerns.
- Maintain assigned work areas in a clean, organized, and compliant condition.
- Follow established procedures for material handling, product segregation, rejected units, samples, and waste disposal.
- Collaborate with Quality Assurance, Manufacturing, Engineering, Maintenance, and other support departments to maintain efficient and compliant operations.
Key Deliverables
The selected resource will be responsible for executing and maintaining:
- Visual inspection activities and product defect classification records.
- Product inspection results, sampling records, and reconciliation documentation.
- Pharmaceutical packaging operations and completed batch records.
- Packaging line setup, clearance, and in-process verification records.
- Packaging component and printed material verification records.
- Product identification, traceability, and material reconciliation documentation.
- Equipment operation and inspection process records.
- GMP logbooks, operational checklists, and supporting documentation.
- Training and qualification records for assigned activities.
- Documentation supporting investigations, audits, and process improvement initiatives, as assigned.
