Location: Vista, CA
Schedule: M-F 5am-1:30pm/6am-2:30pm/7am-3:30pm (To be discussed with Manager)
Salary: $21/hour-$23/hour
POSITION SUMMARY Performs inspection of raw materials, packaging components, intermediates, 3rd party bulks and finished goods for compliance to our established Acceptable Quality Limits (AQL). Pulling samples from each lot of materials for testing and retention. Adherence to applicable standard operating procedures (SOP), Good Documentation Practices (GDP) and Common Good Manufacturing Practices (cGMP) as applicable to individual tasks. Maintains Master Incoming Inspection Tracker, a shared business tool, to ensure visibility of all material status’ throughout their release cycle period Performs staging of raw materials, packaging components, intermediates, 3rd party bulks and finished goods for the QA Inspection Team; Returns inspected products back to the warehouse racks after inspection and assists in ensuring all materials have a disposition affixed to every pallet and support changing the disposition markers as the material’s status changes. Maintain safety practices and Forklift Certification, as required for this position.
ESSENTIAL FUNCTIONS Reasonable Accommodations Statement To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Function Statement(s)
1. Performs staging with the forklift of raw materials, packaging components, labels, intermediates, 3rd party bulks for QA Inspection 2. Affix disposition placards on all pallet on all lot of material that has been inspected by QA and or by the QC Lab (when appropriate) 3. Performs inspection of raw materials, packaging components, labels, intermediates, 3rd party bulks and Finished Goods; pulling the required samples (per the Sampling paperwork) for testing, in the time limit and priority specified 4. Prints and/or completes all required documentation in the applicable sampling specification report and on an Inventory Card. Documents any quality-related product findings on the sampling and/or inspection report 5. Affix disposition placards on all pallet on all lot of material that has been inspected by QA and or by the QC Lab (when appropriate) and the same disposition on the Inventory Card 6. Updates and maintains the Master Incoming Inspection Tracker for the inspection results, date and inspection reports (where applicable) 7. Reports any general safety hazards to Materials and Compliance Specialist, QA Manager, QA Director 8. Performs any other duties assigned by Supervisor or Manager, to include and not limited to, retrieving retention samples, or pulling extra samples, as per management’s request, in the time frame and priority requested 9. Performs weekly and monthly tasks that include and are not limited to, replacing chart recorders, settling
plates, destruction of raw materials… as needed. 10. Performs other duties as assigned.POSITION QUALIFICATIONSCompetency Statement(s)● Positive – Ability to view all situations with a positive attitude● Willingness – Possesses willingness to learn new skills and use new tools and methods● Innovative – Ability to look beyond the standard solutions and “think outside the box”● Detail Oriented – Ability to pay attention to the minute details of a project or task● Enthusiastic – Ability to bring energy to the performance of a task● Friendly – Ability to exhibit a cheerful demeanor toward others● Initiative – Ability to make decisions or take actions to solve a problem or reach a goal● Organized – Possessing the trait of being organized or following a systematic method of performing a task● Reliability – The trait of being dependable and trustworthyEducation:● High school diploma or GED required.Experience:● Experience in the pharmaceuticals industry is highly preferred but not required● Experience Required:
2+ years● Forklift certified (standing and sitting)● Able to lift, bend, climb and reach ● Effective communication skills, including ability to read and write in English (Bi-lingual language skills inSpanish, helpful but not required)● Previous QA experience highly preferred● Flexibility in work hours preferred● Team player, excellent work ethics and able to multitask, attention to details as well as flexibility tochanging prioritiesComputer Skills:● Analytical, computer and mathematical skills.
