Material Quality Specialist

Benefits

Additional Information

Nature and Scope Responsible for ensuring that raw materials, primary containers and packaging components used in the manufacture of products for American Regent Inc. meet the established standards of quality. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. - Creates monthly reports such as Annual Product Review (APR) and metric documents for the Material Quality Management department. - Assist in drafting and/or revising Quality policies and procedures. - Assist Material Quality Management in interpreting and implementing quality assurance standards. - Assist with initiating deviations (events) for components that do not meet specifications. - Assisting with corrective actions as a result of deviations and audit findings. - Oversee the implementation and efficiency of quality and inspection systems. - Collect and compile statistical quality data. - Facilitate and evaluate audit findings of internal audits. - Work independently on assigned projects. - Assist with the completion of corrective action tasks. - Support quality audits and document control. - Collaborate with other Quality staff to accomplish all daily tasks on-time and with a high level of quality. - Mentor Quality team members and share expertise. - Collaborate with other departments as needed on company processes. - Provide department specific orientation and training for new hires. - Identify training needs and organize training interventions to meet quality standards. - Drives Core Competency Model initiates in support of enhanced organizational performance. - Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. - Bachelor's degree or 8 years of equivalent work experience, required. - 5-7+ years' experience in Quality inspection, auditing, or testing within the pharmaceutical industry is required. - Experience with investigation writing and implementation of corrective action programs. - Proficiency in Microsoft Office, specifically Word and Excel, for creating reports and maintaining spreadsheets - Strong written and verbal communication skills - Ability to multi-task and work independently with minimal supervision. Physical Environment and Requirements - Must have 20/20 vision, corrected if necessary. - Must successfully pass Color Blindness Screening (D15). Expected Salary Range: $79,900-87,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal ( eeoc.gov ) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: - All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. - Our recruiting process includes multiple in person and/or video interviews and assessments. - If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. - We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com .