Neurodiversity Advisors Inc. Jobs

Mobile Neurodiversity Advisors Logo

Job Information

Rose International Quality Assurance Associate Specialist in Carlisle, Pennsylvania

Position Title: Quality Assurance Associate Specialist Position Number: 359437 Location: Carlisle, PA 17013 Position Type: Temporary Required Skill Set: Documentation, GMP, Quality Assurance Position Description: **Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**Job Number: 20352-1Title: Quality Assurance Associate SpecialistDuration: 10 MonthsStart Date: 2/15/2021Location: Carlisle, PA 17013As a Quality Assurance Associate Specialist, you will be the first line for operational quality advice and support for Production and other site areas. You will drive early detection and help prevent potential quality issues.andbull; Supports the release team by performing review of GMP documentation on executed batch records and assisting with resolution of issues in a timely mannerandbull; Completes real time record reviews as manufacturing records are generated and coaches or mentors individuals to build site capabilityandbull; Provides Quality Oversight for the production areas including Manufacturing, Packaging, and Warehouse and consults on quality issuesandbull; Investigates and completes Consumer Complaint Investigation Reportsandbull; May assist or lead Quality Risk Assessmentsandbull; May lead or support changes at the site through the Change Management Processandbull; Leads/facilitates/participates/completes cross-functional team investigations utilizing root cause analysis toolsandbull; Assists in completion of CAPA assigned within the Quality Departmentandbull; Participates in GMP audits and provides product knowledge and support for regulatory responsesandbull; Works across multiple value streams to promote a quality culture and support continuous improvementandbull; Maintains effective communication and partnership with Operations and Materials Management departmentandbull; Coordinates delivery of product samples to the laboratory for shipment, storage, and testingandbull; Adapts to changes in the work environment and must be able to change shifts or work overtime and/or weekends as needed.andbull; Other duties, responsibilities and qualifications may be required and/or assigned as necessary.QUALIFICATIONS:andbull; Bachelor's degree in a scientific discipline from an accredited college or university preferred. Candidates with an Associate Degree and a minimum of 2 years of cGMP experience, or a high school diploma with 4 years of cGMP experience in a manufacturing environment may be considered.andbull; Ability to demonstrate accuracy and thoroughness while completing work in a timely manner.andbull; Strong attention to detail and organizational skills.andbull; Knowledge of Technical Writing techniquesandbull; Effective interpersonal and communication skills.andbull; Follows instructions, policies, and procedures.andbull; Minimum 1 year of cGMP experience preferred.PHYSICAL/MENTAL REQUIREMENTS:While performing the duties of this job, the employee is regularly required to stand; walk, climb stairs or ladders and use hands to handle, or feel. The employee is occasionally required to reach with hands and arms. The employee must regularly lift and/or move up to 50 pounds. The employee is regularly exposed to moving mechanical parts or airborne particles. The noise level in the work environment is usually moderate to loud. The employee must be able to distinguish colors accurately.These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. Benefits: For information and details on employment benefits offered, visit here. If you have any questions/concerns, please contact our HR Department via our secured website. Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without re