Description: PDS Tech, Inc. is seeking a QA Contractor in Bridgewater, NJ
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.
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.
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
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.
Proven ability to be assertive and influence others and lead significant change.