Quality Systems Technician I
APR Consulting, Inc. has been engaged to identify a Quality Systems Technician I
Location: 5105 S National Dr Knoxville, TN 37914
Position: Quality Systems Technician I
Pay Rate: $18.70/hr
Duration: 3-months initially with potential to extend/convert based on performance.
Schedules/Shift available: 5pm- 5am (Night shift)
PURPOSE AND SCOPE:
Conducts Quality audits of products assuring company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems. Functions as an information source to employees when quality issues occur.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Under close supervision, prepares, performs, and controls raw material/packaging material incoming inspections and Material Inspection Reports.
- Verifies and records the receipt of components and their condition upon arrival. Documents condition of nonconforming components (description, photographs, etc.) for Material Review Board (MRB) disposition.
- Assigns lot control identification to all incoming production components (chemical components, packaging components, etc.).
- Samples and inspects packaging and chemical components according to approved procedures to ensure conformance with specifications.
- Performs inspections/audits of the process to ensure conformance with SOP procedures and identification as needed.
- Prepares and issues all finished product labels in accordance with established label control procedures.
- Prepares samples for internal laboratory testing or for shipment to an appropriate testing facility
- Reconciles all finished product labels.
- Records, counts, interfaces with issuing facility, and maintains/adjusts the label inventory as necessary.
- Receives and inspects the incoming product labels.
- Maintains effective communication with vendors.
- Assists with validations as required.
- Cleans and maintains inspection work areas.
- May be required to assist with the testing of raw materials in the Chemistry Lab.
- May be assigned to assemble device history records (DHR) for issuance to production.
- May be assigned to review finished DHRs for completeness and correctness.
- May be responsible for DHR postproduction review and compiling of error metrics – Dry and Liquid.
- Works cross-functionally in other area of the QS unit.
- Conduct process audits to monitor the effectiveness of controls.
- Participates in continual improvement projects.
- Collects, analyzes, and reports performance data related to assigned responsibilities.
- Works on assignments that are routine in nature, requiring limited judgment.
- Contacts are primarily within immediate work unit.
- Normally receives detailed instructions on all work.
- May refer to higher level staff for assistance with day-to-day problems that may arise.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various projects as assigned by direct supervisor.
- Other duties as assigned.
EDUCATION:
- High School Diploma required.
- 1 year of college or technical school preferred, or equivalent experience and training in quality systems/material inspections.
EXPERIENCE AND REQUIRED SKILLS:
- 0 – 1 year of related experience in a chemical, food, or drug manufacturing facility, or in a quality related role.
- General knowledge of GMP regulations and standard quality control inspection techniques.
- Must have good organizational skills, and ability to perform work in a team environment with a minimum level of supervision.
- Must be detail oriented and be capable of interpreting drawings/specifications.
- Must be capable of applying inspection/sampling plans/techniques to verify if materials/components conform to the applicable drawings/specifications.
- Must have an aptitude for math with basic algebraic skills and measurement skills.
- Ability to prepare routine administrative paperwork.
- Records maintenance skills.
- Knowledge of the structure, policies and procedures of FDA regulated facilities (21 CFR Part 820 Medical Devices).
- Skill in the use of personal computer and related software applications.
About our Client:
A healthcare client providing comprehensive solutions for people living with chronic kidney disease and related conditions, we are working together to improve the quality of life of every patient, every day. We are transforming healthcare through research, innovation, and compassion.
About APR:
Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Don't miss out on this amazing opportunity! If you feel your experience is the match for this position please apply today and join our team. We look forward to working with you!
APR Consulting, Inc., is one of the most trusted talent acquisition and workforce solutions providers in the United States. Known for exceptional responsiveness, agile strategies, and consistently high-level talent, the firm has become a go-to for organizations and managed services providers navigating complex change and urgent challenges. Since its founding in 1980, APR has transformed from a California IT-focused staffing firm to a full-service solutions provider filling a wide range of positions and serving over eight industries — including aerospace and defense, healthcare, IT, telecom, hospitality/gaming, sports/entertainment, government, and utilities –– in all 50 states, with a loyal roster of more than 850 specialized professionals.