QA Inspector

Stefanini

Medina, NY
2 days ago

$26.75 Per Hour
Temporary
Contractor

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Skills

Application Integrationunmatched
Biotech and Pharmaceuticalunmatched
Capability Maturity Model (CMM)unmatched
Communication Skillsunmatched
Consultingunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Customer Trainingunmatched
Data Entryunmatched
Detail Orientedunmatched
Documentationunmatched
ERP (Enterprise Resource Planning)unmatched
Electronics Manufacturingunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Financial Servicesunmatched
Fortune 1000 Customersunmatched
Governmentunmatched
High School Diplomaunmatched
Information Technology & Information Systemsunmatched
Information Technology Consultingunmatched
Information Technology Outsourcingunmatched
Infusion Pumpsunmatched
Java IDE (Integrated Development Environments)unmatched
Lift/Move 25 Poundsunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Nearshoringunmatched
Process Control Engineeringunmatched
Pumpsunmatched
Quality Assuranceunmatched
Record Keepingunmatched
Recruiting Strategyunmatched
Spreadsheetsunmatched
System Integration (SI)unmatched
Telecommunicationsunmatched
Testingunmatched
Wireless Communicationsunmatched

Description

Stefanini Group is hiring!

Stefanini is looking for QA Inspector in Medina, NY

For quick Apply, please reach out to Sahnaj Pervin- call: 2489360650 / email: sahnaj.pervin@stefanini.com

Work Hours: Mon -Thur (40 hours)

Work Location: Medina, NY

Shift: 1st Shift (5:30 AM to 4:00 PM), OT as needed on Friday.

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 products on the floor for internal investigations and holds.

Perform other duties as assigned.

Job Requirements:

High School diploma or GED.

Preferred experience in a pharmaceutical or Biotech industry helpful.

Must be familiar with cGMP and FDA requirements.

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.

Note: Position requires both a physical exam and a vision test if a candidate is offered the role. The physical exam must be completed prior to the start date, and the vision test will be conducted on-site during training. Clients will facilitate both.

Physical Demands:

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.

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.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process, including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.

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Numbers & Facts

Location	Medina, NY
Job Type	Temporary, Contractor
Industry	Computer/IT Services
Salary	$26.75 Per Hour
Company Size	10,000 employees or more
Year Founded	1987
Website	http://www.stefanini.com

About Company

Stefanini is a global IT services company with over 24,000 employees across 77 offices in 40 countries across the Americas, Europe, Africa, Australia, and Asia. Since 1987, Stefanini has been providing offshore, onshore and nearshore IT services, including application development and outsourcing services, IT infrastructure outsourcing (help desk support and desktop services), systems integration, consulting and strategic staffing to Fortune 1000 enterprises around the world.

With a base of over 500 active clients, including more than 300 multinationals, Stefanini maintains a strong presence in industries such as financial services, manufacturing, telecommunications, chemical, services, technology, public sector, and utilities. Clients benefit from Stefanini's financial stability, sustained year-over-year growth, and zero net debt. The corporate global headquarters is located in Sao Paulo, Brazil with European headquarters in Brussels and North American headquarters in metropolitan Detroit.

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