Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a, passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. A leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services.
Position: Sr. QA Inspector - 1st Shift
Location: Southington, CT, 06489
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: M - F 6:45 AM - 3:15 PM
Job Description:
Position Summary:
- The Sr. QA Inspector performs testing and inspection of sub-assemblies, final product, commodities, GMP, BOP, safety compliance audits. The Sr. QA Inspector enforces GMP compliance as outlined in internal BOPs.
- The individual is primarily responsible for testing, inspection and release of product and product components and commodities.
- The individual records and reports results to provide information necessary to assure that product has been manufactured in accordance with established quality standards.
Essential Duties & Responsibilities:
- Initiate change requests, BOPs, EPWOs, deviations, NCMRs
- Close-out audit work orders and commodity release
- Complete product and part inspection
- Complete sample pulling
- Complete labeling inspection and control
- Provide line clearance approval
- Monitor GMP practice
- Quarantine and release quarantined materials
- Train new employees and team on GMP and BOPs
- Must perform defect tracking, monthly reporting and data entry
- Complete test requests
- Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FDA, EPA, OSHA, ISO, EEOC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate and material).
- Perform these and other duties as necessary or required, the inclusion of which will not alter the basic scope of the position
- Work on special projects as they arise
- Actively demonstrating support through interactions with solid communication skills, attitude, dedication, commitment, respect, pride and trust.
Qualifications:
- Knowledge, Skills & Qualifications
- Excellent Mathematical knowledge
Education and Experience:
- High School Diploma or GED required
- Four years previous experience as an MQA or QA Inspector preferred
- Experience with medical devices/pharmaceutical GMPs preferred
Physical Requirements and Work Environment:
- While performing the duties of this job, the employee is regularly required to talk or hear.
- This job operates in a clean room environment.
- While performing the duties of this job, the employee may be required to sit or stand for the duration of the shift
- Must be able to repetitively move and lift objects of up to 20 lbs.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Southington, CT |
| Industry | Computer/IT Services |
| Salary | $24 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Biotech and Pharmaceuticalunmatched
- Bug Tracking/Defect Managementunmatched
- Calibrationunmatched
- Change Requests/Ordersunmatched
- Cleanroomunmatched
- Communication Skillsunmatched
- Corporate Policiesunmatched
- Data Entryunmatched
- Diversityunmatched
- Document Managementunmatched
- Environmental Protection Agency (EPA)unmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Healthcareunmatched
- Healthcare Qualityunmatched
- High School Diplomaunmatched
- Housekeeping/Cleaningunmatched
- ISO (International Organization for Standardization)unmatched
- Intravenous Therapiesunmatched
- Lift/Move 20 Poundsunmatched
- Maintain Complianceunmatched
- Mathematicsunmatched
- Medical Equipmentunmatched
- OSHAunmatched
- Preventative Maintenanceunmatched
- Product Controlunmatched
- Quality Assuranceunmatched
- Quality Metricsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Safety Complianceunmatched
- Safety Trainingunmatched
- Staff Trainingunmatched
- Testingunmatched
- Workforce Managementunmatched
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