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Quality Assurance Specialist I

Company: ISG
Location: Morristown
Posted on: November 23, 2022

Job Description:

Job Posting ID: ZBRAJP00006034Job Posting Title: Quality Assurance Specialist IContract Period: 11/28/2022 to 11/28/2023Pay Rate: $24.00 hr.Shift Type: Day Shift
Work Location:116 The American Road, Morristown, NJ 07950

Description:Responsible for fulfilling the requirements of the Quality Management System, including Document Retention, Document Control, Calibration, and Regulatory Affairs functions. Responsible for assisting with the batch record reviews for final release of product.
Essential Duties and Responsibilities:To perform this job successfully, a qualified individual must be able to perform each essential duty satisfactorily either with or without reasonable accommodation. The requirements listed in this job description document are representative of the knowledge, skill, and/or ability required.
Maintains inventory and distribution of lab notebooks.
Assists with calibration, maintains calibration files of outside vendor calibration services, assists outside vendor during their visit, and initiates CAPA's for failed calibration(s).
Shares responsibility for reviewing subcontractor records for release of product.
Assists with customer and registration audits - retrieves (scans or make copies of) documents when needed.
Manages record retention: prepares records for offsite storage, manages destruction/shredding.
Maintains back-up electronic copies of all protocols and validations, updates logs with approval dates, distributes protocol copies if needed.
Shares responsibility for reviewing QC records for release of product and verifying Certificate of Analysis and Lot Analysis.
Provide administrative support to CAPA, Complaint, and Regulatory Affairs functions: drive timely closure of CAPAs and continual improvements by identifying upcoming and past due actions and communicating with those responsible.
Support Regulatory function by compiling and sending required documents to FDA and other applicable regulatory bodies.
Maintains and adheres to all company safety policies and procedures.
Maintains work area organization and documentation to satisfy ISO and GMP standards.
Maintains good communication and working relationships with all departments and effectively functions within a team environment.
Exhibits professional etiquette that exemplifies the values of the organization.
Qualifications & Competencies:Language Ability:Good verbal and written communication skills necessary.
Math Ability:Knowledgeable in the use of statistical methods; ability to interpret graphs and communicate results.
Reasoning Ability:Ability to read and interpret data, including graphs, as they relate to test results. Ability to collect pertinent data, establish facts, draw conclusions and identify problems.
Other:Good writing skills, and good organization skills such as prioritization, filing, and time management
Education and Experience:Two or Four-year degree or equivalent Quality experience preferred, plus minimum three years additional quality management system experience.ISO and/or GMP experience is preferred.
Computer Skills:--- Word processing--- Spreadsheet (Excel)--- E-mail software in a Windows environment--- Control software (for document control)
Certificates and Licenses
No certification necessary
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is occasionally exposed to moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and extreme cold (ie. during audit-related interactions or follow-up activities with employees working in production/lab areas). The noise level in the regular work environment/office is quiet. Gowning procedures are required in specific areas.
Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to sit while performing the job function (computer work, document and record reviews, meetings, etc). The employee is occasionally required to stand, walk, stoop, kneel, or reach in order to move about the office to access files, office machinery, and meeting locations, or to participate in audits. The employee is occasionally required to lift up to 50 pounds. The vision requirements include close vision and distance vision.

Keywords: ISG, Newark , Quality Assurance Specialist I, Other , Morristown, New Jersey

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