Job Listing Description

QA Contractor

Description:
PDS Tech, Inc. is seeking a QA Contractor in Bridgewater, NJ

Position Summary:



  • Under the direction of the Sr. Manager Quality Assurance, the Quality Assurance Associate- Contractor will be supporting the site to assure that the Quality Management System and manufacturing processes are in compliance with ISO/cGMP Quality Management System to produce consistent quality product.


Responsibilities:



  • Support Drive Quality System deliverables: Nonconformances, Deviations, Customer Complaints and CAPA to align with site performance and turn-around-time metrics
  • Conduct and lead the investigation and analysis of reported customer complaints per Quality Management System procedures using problem-solving methodology to identify root cause.
  • Initiate and manage through to closure investigations, complaints and work with Operational partners to ensure investigations are completed accurately and in a timely fashion.
  • Assist in performing internal audits under ISO 9001:2015
  • Assist with executed records retention logging, transport and record requests from off-site records retention site.
  • Perform routine Quality System driven Gemba walks of the area and partner with area representatives on identification and implementation of area related process improvements.
  • Identify training gaps based on the area training matrix and assist with closure of those gaps.
  • Support continuous quality improvement efforts and learning opportunities for the area.


 




    Minimum Requirements/Qualifications:



    • Position requires a Bachelors of Degree in Engineering, Science or equivalent experience with at least 2-4 years with identified above responsibilities in a Quality Assurance role in an ISO/cGMP, pharmaceutical, or medical device environment.
    • Proven track record of hands-on problem solving expertise in a manufacturing environment.
    • Proficiency of Excel, Word, PowerPoint, including data analysis and statistical methods.
    • Ability to present to various levels of internal and external stakeholders.
    • Ability to travel between our two facilities in New Jersey (Bridgewater and Fair Lawn) on occasion.
    • Any electronic quality system experience such as Track wise, LIMS, Agile is plus
    • Strong technical writing skills for investigations


    Professional Characteristics:



    • Results oriented work attitude that exhibits initiative, energy, drive, creativity, collaboration, assertiveness, diplomacy, risk-based decision making and ambition.
    • Excellent interpersonal skills: ability to be a team player, build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.


    Leadership Skills:



    • Proven ability to be assertive and influence others and lead significant change.
    • Strong verbal and written communication skills.
    • Adaptable to change

     
    Job Number: 2110133029
    Job Location: Bridgewater, NJ
    Duration: 12 months
    Input Date: 11/25/2021
    Firm Name: PDS TECHNICAL SERVICES
    Attention: Mike Avillion
    Address: 2154 N CENTER ST STE 405D
    City, State: NORTH CHARLESTON, SC 29406
    800 Phone: 866/224-2745
    Email: southeastjobs@pdstech.com
    Website: https://pdsjobs.force.com/candidates/job_detail?id=a1i1T000003PrRiQAK&URLSource=cjhunter

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