Analytical QA Associate

Job Description Job Title: Quality Assurance (QA) Associate III – Analytical Work Location: Fall River, MA Job Purpose The purpose of the QA Associate III - Analytical position is to monitor and ensure product and analytical quality is maintained throughout all phases of the analysis process in compliance with established specifications and standard operating procedures (SOPs). Duties and Responsibilities 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 deadlines. No employment sponsorship or work visas. MUST HAVES: 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. Job Type: Full-time Pay: $70,000.00 - $75,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Relocation assistance Vision insurance Schedule: 8 hour shift Day shift Monday to Friday Experience: Pharmaceutical: 5 years (Preferred) hplc: 3 years (Preferred) QA Associate: 5 years (Preferred) Work Location: In person