Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
QA Audit Technician II - 1st Shift
Pay: $20
Location: Middletown, VA
Position Summary:
Responsible for implementing and maintaining the efficiency of the quality system.
Perform product audits via documentation through batch record review of raw materials, components, bulks, and kits.
Prioritize work based on ship dates, backorders, and projects.
Review, maintain and provide, as requested, documents and records to satisfy international regulatory requirements.
Assemble documentation requested for product registrations, failure investigations, and other regulatory requirements.
Maintain lot history files of batch records for each product released from this operation. This includes filing, retrieving, and cataloging.
Acts as a resource to operations teams and problem-solving groups and aids in resolution of problems
Assist the SAP Coordinators when needed by performing vital MRP/SAP system task activities as part of batch record reviews.
Alternate work schedule and extended hours will be required to support changes in manufacturing schedule and the need to meet customer expectations on delivery times. Weekend work may be required but minimized as much as possible.
Review/maintain current customer specifications to ensure the released specifications align with the customer's expectations.
Perform other duties as assigned.
Minimum Requirements/Qualifications:
Minimum requirement High School Diploma, preferred bachelor's degree in, Science or applicable field.
Minimum of 2 years of accumulated experience in QA or Quality Control.
Requires a basic understanding of the practices, principles, and theory of GMP Services
Shown understanding of the metric system with a focus on weights and volumes. Able to follow/supervise math calculations.
Communicate effectively both verbally and written with personnel at all levels in a professional manner.
Function in a team environment and receive direction and mentorship primarily from peers with minimal direction from management.
Detail oriented and can coordinate multiple activities at once.
Must be a self-starter who can take general concepts and direction and produce desirable results.
Performs other duties as assigned.
Required Hiring Criteria:
Strong oral and written communication skills. Ability to read, write, and speak English fluently.
High attention to detail.
Ability to work both independently and as a team member
Basic understanding of Quality practices, cGMP regulations and ISO 9001 and ISO 13485 standards.
Strong leadership skills with the ability to challenge, influence, and build consensus.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
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