Materials Quality Supervisor

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.

• Supervises and coordinates activities of workers engaged in sampling, inspecting and testing of primary drug components (raw materials), primary packaging, applying knowledge of quality assurance standards and procedures.
• Supervise and coordinates activities of workers engaged in supplier notification activities.
• Directs workers in quality assurance inspection and testing, to assure that SOP’s and regulatory standards are met.
• Assigns training of new workers to qualified workers.
• Reviews/Approves reports and confers with quality assurance, production, management, and engineering personnel to solve work-related problems.
• Draft/revise quality assurance policies and procedures.
• Interpret and implement quality assurance standards.
• Evaluate adequacy of quality assurance standards.
• Devise sampling procedures and directions for recording and reporting quality data.
• Review the implementation and efficiency of quality and inspection systems.
• Collect and compile statistical quality data.
• Initiate events, perform Root Cause Analysis, Impact Assessments, CAPA’s and Effectiveness Checks related to Incoming material and assist other departments with Investigations as required.
• Manage the Destruction Approval (DAF) of material process which includes assigning DAF numbers and disposition of material to be disposed of.
• Facilitate and evaluate audit findings, implement appropriate corrective actions.
• Drives QUALITY culture and Core Competency Model initiatives 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 equivalent work experience.

• Minimum 5 or more years’ experience in industry.

• Quality inspection, auditing and testing experience.
• Experience with investigation writing and implementation of corrective action programs.
• Product or industry-specific experience.
• Knowledge of relevant regulatory requirements.
• Proficient in MS Word, Excel and Outlook.
• Strong oral and written communication skills.
• Strong time management and organizational skills, able to delegate tasks as needed.

 Physical Environment and Requirements

• Must have 20/20 vision, corrected if necessary.
• Must successfully pass Color Blindness Screening (D15).

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

·         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