Duties and Responsibilities This QA Associate III – Analytical position is an individual contributor role and is a member of client’s QA Team at the Fall River, MA (Unit IV) site . The position reports to the Site QA Lead. The essential and typically expected job duties for this position include but are not limited to the following: * Review data generated in the laboratory is accordance with stablished criteria set forth in SOPs and established specifications * Assemble quality data to support management review meeting requirements * Issuing, reviewing, maintaining, and archiving of laboratory logbooks * Scanning of laboratory approved finalized qualification for easy accessibility by all department * Training and execution of internal audits, as required * Review/approval of calibration records for analytical instrumentation and equipment * Identify and report any non-conformances and/or discrepancies to management if applicable. * Complete other duties or participate in project work as assigned by management. Education and Experience * Minimum bachelor’s degree from an accredited college/university in relevant field of study such as Chemistry, Pharmaceutical Science, or other Life Science discipline. * Advanced training or education in pharmaceutical quality compliance or related field of study from an accredited college/university.is preferred. * Minimum of three (3) years’ experience in quality assurance in a current Good Manufacturing Practice (cGMP) pharmaceutical work environment. * Experience in metered dose inhalation (MDI) preferred. * Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications. Physical and Work Schedule Requirements * Independent, unassisted lifting up to 10 kg, may be required. * Able to always wear appropriate personal protective equipment (PPE) such as safety glasses, shoe covers, hard hat, lab coat and other PPE, when required. * Sitting at a desk and/or working at a computer or other “screen” 75% or greater of an 8-hour period. * Typical work schedule is Monday through Friday, 9 AM to 5:30 PM. Some weekends may be required based on business needs. Professional and Behavioral Competencies * Must be able to work under general supervision and able to work independently and in a team environment. * Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals. * Must be able to exercise appropriate professional judgment on matters of significance. * Effective interpersonal relationship skills and the ability to work in a team environment. * Proficiency in the English language to include usage, spelling, grammar, and punctuation. * Must have current Good Manufacturing Practices (cGMP) knowledge. * Must have strong attention-to-detail. * Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed. * Must have strong organization and communication skills (written, verbal, and presentation). * Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadline
Job Type: Full-time
Salary: $70,000.00 – $85,000.00 per year
Schedule:
Ability to commute/relocate:
Experience:
Work Location: One location
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+91 7760214145