We are looking for an Incoming Associate to follow current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP) to record all procedures in a timely manner. The Associate will understand and follow Standard Operating Procedures (SOP) in all functions executed and report any deviations where necessary.
Roles and Responsibilities:
- 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 inspect all incoming materials for identity, quantity, and damages. The QCIA will be responsible for reporting any discrepancies throughout the receiving process.
- The QCIA will be responsible for using the appropriate applications and forms to document the receiving and inspection process. This includes, but is not limited to, inspection forms, disposition labels, inventory sheets, inventory tracking software (Navision), and receiving/sampling logs.
- 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 and master proofs.
- The QCIA will be expected to navigate through software programs, including but not limited to: Microsoft Suite (Excel, Word), Navision, LIMs, and SAP.
- The QCIA will be expected to work independently and 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 used in sampling is cleaned, calibrated, and properly maintained.
- Communicate effectively with other departments within the organization and function within a team environment.
- Regular attendance is required
- Perform other assigned duties as may be required in meeting company objectives.
Minimum Requirements: Proficient in computer work processing and Microsoft Office applications. Ability to lift (up to 50lbs or by team lift) and maneuver material up to 100 lbs. Good written and oral communication skills that enable them to communicate well with other QCIA’s and other departments.
Education and Experience: Minimum of Associates in Arts (AA) or a combination of higher education and two years’ experience in a regulated cGMP environment. Experience in a Quality environment is preferred.