Roles and Responsibilities:

• The Quality Control Incoming Associate (QCIA) will follow current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP) to record all procedures in a timely manner. The QCIA will understand and follow Standard Operating Procedures (SOP) in all functions executed and report any deviations where necessary.
• The QCIA will inspect all incoming materials for identity, quantity, and damages. The QCIA will be responsible for reporting any discrepancies throughout the receiving process.
  • The QCIA is responsible for receiving materials using a Powered Industrial Vehicle (forklift, pallet jack).
  • The QCIA is responsible for reading and understanding all accompanied paperwork, which includes, but is not limited to: packing slip, bill of lading, Certificate of Analysis (CofA), and Certificate of Compliance (CofC).

• The QCIA will be responsible for inspecting and sampling incoming materials to ensure they meet quality standards. All materials will be inspected and sampled according to the material specifications, component specifications and master proofs.
• The QCIA will be responsible for using the appropriate documents and software programs during the receiving, inspection, and releasing process. This includes, but is not limited to, inspection forms, AQL forms, disposition labels, Microsoft Suite (Excel, Word), LIMs, and SAP.
• The QCIA will be expected to work independently and/or with other QCIA's with minimal supervision.
• Maintaining a safe working environment by following all safety guidelines/regulations and wearing Personal Protective Equipment (PPE) as appropriate. This person will ensure that all equipment and work area used is clean, calibrated, and properly maintained.
• Regular attendance is required.
• Perform other assigned duties and follow verbal and written instructions issued by supervisor or designee related to meeting company goals and objectives.
• Communicate effectively with your team, supervision and other departments within the organization and function within a team, promoting positive work environment

Minimum Requirements: Proficient in computer work processing and Microsoft Office applications. Ability to lift (up to 55lbs or by team lift) and maneuver material up to 110 lbs. Good written and oral communication skills that enable them to communicate well with other QCIA's and other departments.

Education and Experience: Equivalent combination of college level coursework with one-year experience in a regulated cGMP environment.

Supervisory Responsibilities: None