Position Title: Quality Assurance Specialist II or III (depending on the candidate’s experience)
Reporting to: Quality Assurance Manager
The Quality Assurance Specialist III is a crucial role in conducting all aspects of Quality Assurance within KLS’s assigned business project portfolio. He/she is responsible for managing, coordinating, facilitating and implementing quality assurance standards based on applicable FDA, ICH, and ISO requirements across all KLS products. The incumbent in this position directly reports to Quality Assurance Manager and holds a key role in assisting management with the development and implementation of internal controls, standards, processes and procedures for managing the company’s QMS and quality programs. The incumbent directs quality assurance methods, participates with internal Quality training for all KLS employees, monitors production conformance with QA standards and procedures, and participates in creating methods for overall process improvement for KLS’s products and processes.
Specific Duties and Responsibilities:
· Participate in the development, implementation, management and integration of a Quality Management System (QMS) for all KLS production activities and products.
· Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls).
· Conduct employee training on applicable Quality SOPs, regulatory requirements and ISO/ICH standards under the guidance of Quality Management.
· Serve as the initial contact and quality control resource for quality event or nonconformance identification, report write-up and quality event documentation/investigation.
· Proposes appropriate correction, corrective action plans and measures and effectiveness verification for CAPA/Deviation resolution and closure.
· Review/release regulatory document packages (including batch records, CoAs and other related documents) for each KLS product lot.
· Generates/approves applicable records including Certificate of Conformance and/or Certificate of Analysis for KLS product lot/batch releases.
· Participate in the design, implementation and documentation of procedures for process control, process improvement, testing and inspection.
· Maintain/generate quality metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
· Perform root-cause analysis and other problem-solving activities utilizing appropriate failure investigation tools (e.g. 5 “Whys”, Fishbone, 6M’s etc.) to identify effective corrective and preventative actions, measures and process improvements.
· Maintain collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
· Conduct quality review of documentation including test protocols, summary test reports, IQ/OQ/PQ reports and data for process, test method, equipment, facilities, software or other system validation and qualification activities, as needed.
· Review suppliers purchase orders, establish and ensure supplier quality requirements are met and implement supplier quality corrective actions as appropriate per procedure.
· Perform internal and participate in external customer or notified body quality audits.
· Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program. Maintain ASL as required.
· Prepare audit plans, agenda and final reports based on audit findings as appropriate,
· Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action plan is implemented.
· Other duties as assigned or identified by Quality Management.
- Bachelor’s degree in Science or equivalent work experience.
- Must be self-motivated and carry on the responsibilities without much supervision.
- Experience (3-5 years) working in a GXP or ISO regulated environment.
· Experience (1-3 years) in a Quality Assurance related role
- Must have excellent skills in organization, negotiation, problem solving and time-management.
- Able to attend to detail and act decisively.
- Ability to travel domestically or international (~10%).
- Ability to work under pressure, manage several tasks at once and meet tight deadlines.
- Must have excellent interpersonal, written, oral presentation and verbal communication skills.
- Proficient in Microsoft Word, PowerPoint, Access and Excel.
Physical Job Requirements:
Office/Lab environment. Lifting to 40 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.