Inspector, Incoming

Job purpose

The main responsibility of this position is to perform the sampling and inspection of raw materials, packaging components, incoming bulks and contract finished goods.  This role is required to ensure compliance with SPCI procedures and policies, as well as to ensure Canadian and FDA regulations are maintained in areas of responsibility and to report deviations where required. 

Duties and responsibilities

• Sample, physically inspect and perform required tests on packaging components, ensuring documentation is complete, accurate and correct prior to forwarding to QA for review and disposition.
• Visually inspect, sample and perform required tests on incoming raw materials, bulks and contract manufactured finished goods as per SOPs, ensuring documentation received and prepared is complete, accurate and correct.
• Provide daily updates to QA Manager on daily activities and provide rationale for delays ensuring the estimated timeframes are met where possible.
• Perform routine monitoring and data collection of warehouse temperatures. 
• Perform inspection and assessment of returned goods.
• Perform routine calibrations of weigh scales, gauges and other miscellaneous testing equipment within the established timeframes.
• Perform non-routine sampling and/or inspection for retest, investigations, etc.
• Prepare retention samples of new receipts of raw materials.
• Prepare, review and update written procedures in areas of responsibility.
• Complete all GMP and LIMS Documentation correctly and in a timely manner.
• Records input data on shipments and sampling/inspection progress into computer systems and printed spreadsheets.
• Complete all training assignments and maintain personal training records.
• Participate in deviation investigations, as appropriate.
• Complete Corrective and Preventive Actions (CAPA’s), as assigned.
• Initiate, and follow through with actions required to close Change Controls, as assigned.
• Participate in Internal, Customer and Regulatory Audits, as needed
• Works with QA Incoming Manager, Warehouse staff  and Materials Management personnel to resolve discrepancies identified during the process.
• Work efficiently and professionally with other departments to proactively build quality into related processes and systems.
• Other duties as required

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s Degree in science-related discipline is preferred.
• Previous sampling and inspecting experience in the pharmaceutical industry, is an asset.
• Previous experience in the pharmaceutical industry in Quality Assurance or Quality Control, is preferred.
• Knowledge of/previous exposure and application of Canadian and FDA GMPs.
• Strong written and verbal communication skills to communicate effectively with key areas/departments.
• Strong interpersonal skills to facilitate effective interaction with co-workers and other departments (Warehouse/QA, Materials Management, Art Dept., etc.).
• Ability to multi-task with strong organizational skills to organize daily events to meet department requirements and SPCI business needs.
• Ability to work in a fast paced environment and prioritize workload.
• Training in WHMIS.
• Powered Pallet Lift training and experience is an asset.
• Strong computer skills are an asset.

Working conditions                               

• Handling of equipment such as: Pump trucks, Drum Lifters, and vacuum’s
• Must wear safety shoes.
• Handling of pharmaceutical raw materials
• May be required to wear Personal Protective Equipment (PPE) such as safety glasses, rubber gloves, hair net, coveralls, shoe covers  during inspection/sampling activities.
• Unless otherwise discussed in the individual contract, the position of QA Incoming Inspector is considered to be a “rotational shift “based on 37.5 hours per week.
• Work on the afternoon shift for one week a month, may also be required.
• Overtime is required on occasion

Physical requirements

• General conditions include office and warehouse work; mix of sitting, standing, walking, lifting.
• Ability to lift up to 25 kg’s.
• Loading materials onto skids manually or assisted with equipment.
• Standing/bending to inspect, sample and test raw materials, packaging components and contracted Finished goods. Climbing mobile stairs to inspect temperature gauges across various racking locations in the warehouse.