QA Operations Materials Associate

Nature and Scope

This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc.

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.

• Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes.
• Performs sampling of components.
• Conduct verifications and checks through accurate material inspections.
• Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system
• Management of BPCS for verification and disposition of materials
• Maintain retain samples for all primary and secondary components and labeling
• Performance of DAF (Destruction Approval) process for rejected materials
• Use of Trackwise and Veeva for change controls, as needed
• Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.
• Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation.
• Support generation of logbooks and sheets/labels as required.
• Basic knowledge of cGMPs and supporting regulatory documents
• Perform room, area and equipment clearances that may be necessary for this job function.
• Able to perform tasks with minimal error rate.
• Assist other Quality Assurance Operations Associates, as needed.
• 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.

• High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.
• At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred.
• Must be able to do work independently.
• Experience in QA working in a cGMP manufacturing environment (preferred)
• Working knowledge and understanding of quality assurance principles and familiarity with QA programs
• Strong analytical skills, attention to detail and adherence to procedures.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational, interpersonal and communication skills (written and oral) required.
• Ability to take feedback constructively and function in a team-oriented work environment.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

Employee must be able to occasionally lift and/or move up to 25 pounds.

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

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