Quality Assurance Testing Analyst
Title: Quality Assurance Analyst
Location: Fair Lawn, NJ
We are seeking a Quality Assurance Associate for a very important client. 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 company Scientific 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.
Requirement The ideal candidate will possess the following qualifications: Minimum Requirements/Qualifications
Position requires a Bachelor?s 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
• Bachelor's or Master's in Accounting
• CPA or eligibility to sit for the exam
• 3+ years' experience in a reputable public accounting firm
• Commercial Services, Non-profit, Financial Services or Commercial Real Estate industry experience preferred
• Knowledge of audit software CCH, CaseWare, ProSystem Fx or other software a plus
• Exceptional organizational, communication and presentation (verbal and written) skills
CohnReznick does not accept unsolicited resumes from third-party recruiters unless such recruiters are currently engaged by CohnReznick Talent Acquisition Team by way of a written agreement to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that CohnReznick will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.
CohnReznick is an organization committed to diversity and inclusion to drive our business results and create a better future every day for our diverse employees, clients, partners, and communities. We believe a diverse workforce allows us to match our growth ambitions and drive inclusion across the business. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information, please see [ Link Removed ]
Equal Opportunity/Affirmative Action Employer Minorities/Females/Protected Veterans/Persons with Disabilities
Employment is subject to verification of pre-screening tests, which may include background check and credit check