The Quality Assurance (QA) Assistant supports all aspects of Quality Assurance within Kinovate Life Sciences (KLS) and provides routine Quality Systems oversight for processes and operations. The QA Assistant serves as a quality representative/point of contact in support of the day-to-day operations of all functional areas within KLS, including, but not limited to: Production, Quality Control, Material Incoming, Sampling, Shipping/Receiving, Order Fulfillment, Labeling, Packaging and Document Control.
Specific Duties and Responsibilities:
Responsible for executing the full cycle of final product order fulfillment from customer order processing through final product dispensing, packing, labeling and shipping.
Review documentation in support of routine Production and Quality Control operations (e.g.: batch records, test forms, equipment verifications/calibrations/maintenance, line clearance and cleaning records).
General Document Control tasks: controlled document processing/formatting, photocopying, scanning, filing documents and preparing documents for archive.
Routine monitoring of calibrated/qualified equipment at KLS.
Maintenance of the equipment logbook system and temperature log charts.
Perform all assigned tasks in compliance with KLS safety standards, policies, procedures and Quality System requirements (e.g.: ICH Q7, ISO 9001).
Ensure that facilities, equipment, materials, organization, processes, procedures, and products comply with KLS and applicable good manufacturing practices requirements.
Under supervision, release materials and final products.
Under supervision, support internal/external/customer audits and regulatory inspections.
Under supervision, author/revise procedures.
Other duties as assigned or identified.
Bachelor’s degree in Science (Biochemistry/Chemistry preferred) with 0-1 year of experience working in a GXP or ISO regulated environment.
Must have excellent interpersonal, written, oral presentation and verbal communication skills.
Must have excellent skills in organization, negotiation, problem solving and time-management.
Able to attend to detail and act decisively.
Ability to work under pressure with changing priorities, manage several tasks at once and meet tight deadlines.
Ability to work extended hours and/or weekends to support Production and Quality Control activities.
Ability to follow directions exactly as given and be capable of working with limited supervision.
Proficient in Microsoft Word, PowerPoint, Access and Excel.
Physical Job Requirements:
Lifting up to 50 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.
Disclaimer: This job description reflects management’s assignment of essential job duties; and nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time.