Job Listing Description

QA Contractor

Description:
Chipton-Ross is seeking a QA Contractor for an opening in Bridgewater, NJ.

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 the client's 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.

REQUIREMENTS:
Position requires a Bachelorís 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.

EDUCATION:
Accredited Bachelorís of Degree in Engineering, Science or equivalent experience.

WORK HOURS:
Full-Time

 
Job Number: 191911
Job Location: Bridgewater, NJ
Rate: Up to $24.00 DOE
Duration: 12 MOS
Input Date: 06/11/2021
Last Updated: 07/26/2021
Firm Name: CHIPTON ROSS
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: tharrell@chiptonross.com
Website: www.chiptonross.com

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