Corporate Quality Specialist (Audit)

Recruiter
Nice-Pak Products, Inc.
Location
Montvale
Salary
Competitive
Posted
08 Feb 2021
Closes
08 Mar 2021
Job role
Audit
Contract type
Permanent
Hours
Full time
Nice–Pak Products, Inc. (NP) is the global developer, manufacturer, and marketer of pre–moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning, and disinfection products.We're currently looking for a Corporate Quality Specialist (audit) in our Montvale, NJ location.POSITION PURPOSE:The Quality Management System (QMS) Audits Associate is responsible for maintaining the effectiveness of the supplier audit program. This role will coordinate, conduct, and support the external supplier audit program as required. The Audits Associate will also be a key stakeholder in reporting, investigating, and resolving supplier non–conformances both remotely and on–site. The Audits Associate provides global execution of quality system audits of facilities, products, and processes against medical device, drug, and cosmetic regulations and standards. This role assures compliance with global quality systems regulation requirements including, but not limited to, the FDA's Quality System Regulations (21 CFR 210, 211, 820), ISO 9001, the Health Canada Drug Regulations, and the EMA Regulations. This is an ideal opportunity for any individual looking to leverage and develop his/her quality expertise, with an opportunity for career advancement in a dynamic, fast–paced, and challenging work environment.ESSENTIAL FUNCTIONS AND BASIC DUTIES:Conduct and report on external audits of suppliers, labs, and third–party manufacturers in accordance with the Supplier Audit Schedule.Audit suppliers, labs, and third–party manufacturers to applicable regulatory and certifying body standards.Identify and communicate observed risks to cross–functional and management teams.Ensure the audit findings are resolved with appropriate Corrective and Preventive Actions (CAPAs).Monitor findings to ensure the effectiveness of corrective action plans.Collaborate on and maintain the Supplier Audit Schedule.Provide support in the development, and monitoring of the effectiveness of the Quality Management System throughout the organization including measurement, analysis, and trending of policy and objectives implementation, identification of continuous improvement opportunities, training, and management review.Collaborate with R, operations, and other teams to ensure timely commercialization of new products.Assist with writing and review of procedures and instructions for the development of the Quality Management System as required.Assist in site audit readiness activities and provide support during customer and regulatory body audits.Assist with maintaining the Approved Supplier List.Consistently demonstrates good judgment and critical thinking in the performance of compliance activities.DATA ENTRY & INTEGRITY:Prepare and maintain the Supplier Audit Schedule, conduct audits, create audit reports, follow up the status of findings, and input and monitor supplier tracking and trending data.Ensure all information remains confidential and compliant with GDPs and 21 CFR 11 requirements.Demonstrates a high degree of professional and personal integrity.REPORTING & ANALYSIS:Supplier Audit Team, project teams, and commercialization teamMonthly trend analysis, status reporting, and schedulingRisk communicationCLIENT ENGAGEMENT:Service internal needs of procurement, operations, and RProvide actionable, fair, and accurate observations to cross–functional auditor and auditee teamsTECHNICAL EXPERTISE:Strong knowledge of QMS standards including regulations, certifying body of knowledge, best practices, and contract requirements (i.e. GMP, ISO, and local government)Strong commitment to cGMPs, GLPs, and GDPsExperience with problem–solving tools (i.e. fishbone diagram, 5S, visual factory design, FMEA)Solutions driven problem solverRequirements not specified by the customer, but still neededSPECIAL PROJECTS:Audit remediationThird–party audit supportRoot cause analysisPERFORMANCE MEASUREMENTS:On–time completionRobustness of programTraining and certification complianceValues centered executionThe above performance criteria will be measured in the context of the individual's following capabilities:Achievement: Ability to deliver technical work on time, without issue, and in a quality mannerOwnership: Ability to demonstrate strong ownership of assigned projects and project workability to work independentlyPartnership Skills: Ability to work well cross–functionally, communicate effectively and work as part of a team to achieve objectivesEntrepreneurial Skills: Ability to demonstrate creativity in the role, explore new and more efficient ways of working and contribute new product ideasQUALIFICATIONS:EDUCATION/CERTIFICATION:Bachelor's Degree in a technical or scientific field, or equivalent experienceISO 9001:2015 Lead Auditor Certificate or similar QMS auditor certificate preferredREQUIRED KNOWLEDGE:Proficiency in Microsoft Office SuiteWorking knowledge of ISO 9001:2015 standardsWorking knowledge of 21 CFR 11, 210, 211Experience working in an FDA regulated cGMP manufacturing environmentExperience with Master Control modules is preferredEXPERIENCE REQUIRED:Minimum 3 years QA/QC experience in an FDA regulated cGMP manufacturing environmentSKILLS/ABILITIES:Excellent interpersonal and communication skills; ability to explain technical details and risks to other departmentsStrong analytical skills in order to analyze processes and provide solutionsFlexibility and adaptability to work in a high paced environment with strong prioritization skillsSelf–motivated with the ability to work independently or as part of a teamWORKING CONDITIONS:Corporate Office Environment with travel to manufacturing and supplier facilitiesDomestic and International Travel; up to 50%Visit us at LinkedIn#LI–AZ1#LI–NICEPAK Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60–1.35(c)

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