QA Inspector (exp. in Manufacturing/Pharma/Biotech)

Pyramid, Inc

Medina, NY

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JOB DETAILS

SALARY

$24–$26 Per Hour

JOB TYPE

Contractor

SKILLS

Artificial Intelligence (AI), Biotech and Pharmaceutical, Communication Skills, Consulting, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, Drug Manufacturing, ERP (Enterprise Resource Planning), Electronics Manufacturing, Employee Benefits, FDA (Food and Drug Administration), FDA Requirements, Healthcare, High School Diploma, Infusion Pumps, Java IDE (Integrated Development Environments), Lift/Move 25 Pounds, Manufacturing, Manufacturing Execution Systems (MES), Physical Demands, Process Control Engineering, Pumps, Quality Assurance, Quality Control, Short Messaging Service (SMS), Testing, Wireless Communications

LOCATION

Medina, NY

POSTED

1 day ago

Immediate need for a talented QA Inspector (exp. in Manufacturing/Pharma/Biotech). This is a 06+ months contract opportunity with long-term potential and is location in Medina, NY, (Onsite). Please review the job description below and contact me ASAP if you are interested. Job Diva ID: 26-15065 Pay Range: $24 - $26/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Perform the inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules either on paper or in the electronic Manufacturing Execution System Camstar to ensure test procedures have been completed and release specifications are within specifications for final acceptance and release. Perform inspection of the pump or wireless battery module to ensure all visual aspects, including approved labels, are met prior to release of the pump or wireless battery module. Approves the release of the pump and wireless battery modules in the appropriate ERP system, as applicable (JDE B4ONE, JDE GME) Ensures there are no open nonconformances associated with the pump or wireless battery modules in the approved nonconformance tracking system. Reviews the device history log within a pump to ensure final testing has been completed in accordance to the applicable procedure. Accurately record all failing observations using the rework form in Camstar or the nonconformance system as applicable. Dispositions the rework activities of nonconformances and completes the electronic approval and closure process for any non-conformances with the device in the approved electronic system. Ensure process control and maintenance procedures are being followed. Recognize out of compliance/out of tolerance situations and take appropriate action. Inspect Service Parts and approve release of the parts. Assist with identification and containment of nonconforming product on the floor for internal investigations and holds. Perform other duties as assigned. Key Requirements and Technology Experience: Must Have Skills: DHR Review / Documentation Inspection, cGMP & FDA Compliance, Visual Inspection & Quality Inspection, Nonconformance Handling (NCR/CAPA/Rework), Camstar / MES / ERP Systems Knowledge and working application of the following: Measurement equipment. cGMP documentation and FDA Basic ESD requirements Computer based programs Data entry and spreadsheet applications. Perform repetitive motions with hands/fingers. Demonstrated attention to details and accuracy, required. Must have good communication skills. May be required to work flexible hours and overtime on short notice. Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices. High School diploma or GED. Preferred experience in a pharmaceutical or Biotech industry helpful. Must be familiar with cGMP and FDA requirements. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee: Must be able to sit for most of the workday. Ability to stand or walk for long periods as well. Must have good hand to eye coordination and dexterity. Physical Requirements: Dynamic Lifting capability: Must have the ability to lift and carry 25 pounds. Must also have the capability to push and pull a maximum force of 5 pounds 4 feet. Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to: Wearing a static protective smock at all times while in the work area Wearing a ground wrist strap and plugging that wrist strap into the working table if at an ESD sensitive station. Working in close proximity to other employees. Working in an environment that is temperature and humidity controlled. Our client is a leading Healthcare industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here. #telJ2W:CB3

About the Company

Pyramid, Inc

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