Job Title: QA Shop Floor Specialist

　　Location: Summit, NJ

　　Hours/Schedule: Normal business hours

　　Type: Contract

　　Overview

　　A Leading Global pharmaceutical company, with a location in NJ is looking to bring on a QA Shop Floor Specialist to join their team. Candidates with a background in Quality and experience in Pharma, please apply!

　　Responsibilities

　　Audit and disposition executed batch records pertaining to the preparation, formulation, granulation, final dosage form and packaging process of products manufactured at Third Party Manufacturing (TPM) sites.

　　When required compiles required disposition documentation (i.e. Contract Audits, FDA Import Documentation) needed for release of specific products. Maintains files for all lots of materials released by Quality Operations, Ext. Mfg.

　　Ensure product compliance with current specifications, procedures, validation requirements.

　　Alert management on trends noted during the evaluation of manufacturing documentation and verify with the TPM actions taken in order to restate control.

　　Input all necessary information into applicable enterprise-wide systems (Trackwise & SAP) related to third party manufactured products, e.g., lot disposition, product quality complaints, change controls, CAPA.

　　Document errors found during the auditing process and assure adequate corrections are documented.

　　Categorizes and reports documentation errors and deviations in order to notify management of trends and focus on the required corrective measures.

　　Provides input to management on the need of revision of manufacturing instructions based on trends, documentation errors or supplemented information.

　　Participate in Regulatory and Compliance audits FDA, DEA, EU, etc as needed.

　　Exercise leadership, team skills, self confidence, and effective decision making throughout projects.

　　Writes, reviews and implements procedures to assure update with current practices, audits or cGMP. Generates Certificate of Analysis, Certification of Conformance, Release Notifications and other release documentation as required by our customers or regional partners.

　　Participates in investigations related to the areas of supervision in order to monitor, measure and optimize or achieve the QA Department and Company goals.

　　Maintain extensive communication with TPMs and other groups such as Manufacturing Technology, Supply Chain, and Project Management Serves on Fact Finding or other project teams as assigned

　　Other duties as assigned by manager

　　Requirements

　　Education:

　　B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.

　　Experience / Knowledge Desired:

　　A minimum of 3 years of experience in pharmaceutical Quality Control and/or Quality Assurance, with direct experience in drug product release and the use of Quality related enterprise-wide systems, i.e., Trackwise, LIMS (QCMain/Sample MangerÔ) and SAP.

　　Experience in solid dosage forms and parenteral manufacturing desired.

　　Knowledge of compendial requirements, testing standards and specifications, regulatory filing documentation and cGMP, FDA regulations and the ability to interpret and apply them.

　　Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.

　　Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.

　　Must be able to correlate events and determine the action plan required to avoid incidents recurrence and or regulatory exposure.

　　Good verbal and written communication skills essential.

　　Excellent interpersonal skills at every level.

　　Capable to manage multiple priorities.

　　Benefits

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.