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Supply Product Quality Assurance III
3 months ago
Duties and Responsibilities:
- Performs daily verification (verified by) of instrumentation (scales, gauges, etc.)
- Verifies monitoring (temperature, cleaning of cold and hot box storage areas.
- Maintains retain samples logbooks and excel files.
- Identifies and files master samples for componentry in master file system.
- Quality monitoring of quality production activities; incoming component and raw materials activities; and quality inspection activities.
- Perform label verification counts and documentation of receipts, issuance, returns and usage
- Ensure Label control inventory is accurately stored
- Accurately reviews and records data.
- Monitoring of production schedule to ensure samples are inspected in time for production demand
- Verification of component inspection and release of items in system
- Reviews and updates procedures related to their job function.
- Kanban inventory level management
- Component Inspection Record Creation
- Mastery of QMS system creation of documents/ Supplier verification
- Accurately reviews and records data.
- Assessing, updating and creating the Incoming Inspection Records(IR’s) within the QMS system.
- Promotes GMP, safety and continuous improvement culture, to enhance customer satisfaction through accurate inspections.
- Assists in training of SPQA I and SPQA II
- Performs reviewed by and release section of Inspection records for packaging components, including customer supplied items.
- Performs inspection of damaged items, and drafts documentation of event on Material Rejection forms.
- Participate in other activities as assigned by Quality management
- Drafts Notice of Events (NOEs) and Vendor Reports (VCF) when Quality events arise
Qualifications:
Working knowledge of FDA regulations for drugs and/or medical devices.
Knowledge of chemical safety and protective equipment.
Must be able to lift to 25 pounds on a regular basis.
Education:
High School Diploma
Three years' experience working in an FDA regulated pharmaceutical or medical device environment or an equivalent combination of education and experience
Skills:
Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
Attention to detail.
Ability to lift, bend, twist and stand continuously
Ability to wear a full-face respirator.
Ability to perform effectively under conditions of fluctuating workload.
Ability to handle and resolve recurring problems.
Communicate with others clearly and concisely.
Ability to use a personal computer and measuring devices.
Attentive to detail, thorough and accurate
Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
Ability to perform effectively under conditions of fluctuating workload.
Ability to handle and resolve recurring problems.
Communicate with others clearly and concisely.
Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
Strong initiative, technical commitment and contribution to company and departmental goals.
Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
Strong initiative, technical commitment and contribution to company and departmental goals.
