Quality Control Associate - Reagent Manufacturing

Software Guidance & Assistance, Inc., (SGA), is searching for a Quality Control Associate - Reagent Manufacturing for a contract assignment with one of our premier Pharmaceutical clients in Tucson, AZ .

Responsibilities :
The Quality Control Associate - Reagent Manufacturing will be an integral part of a team that performs raw material and finished goods testing. The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment. The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP).

Additionally, maintains production documents, investigates Out of Specification (OOS), and works independently with general guidance from senior team members.

• Perform inspection and testing of raw materials, in-process materials and finished goods in a compliant manner.
• Document test results, complete batch records, document observations and generate reports for qualification testing.
• Conduct data analysis of raw material, in-process and finished goods test results.
• Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods.
• Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements.
• Performs routine maintenance of laboratory equipment outlined by operating procedures.
• May assist in coordinating vendor activities for user maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Perform and lab supply ordering and inventory management in order to support the QC laboratory and adherence to inventory control processes (TECO, Cycle counts, etc), including indirect materials, tissue kanbans, and retain samples.
• Foster and follow an established safety culture, environmental guidelines and procedures for all work performed.
• Formulate reagents with high complexity for material testing process.
• Acts as QC representative in transferring processes from development to QC.
• May assist in testing raw materials for reliability and stability.
• May assist in process monitoring and trending.
• May assist in collecting, interpreting and communicating process metrics for recommended improvements.
• Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment.
• Assist in the development and implementation of testing processes.
• Assist in reagent manufacturing activities unrelated to QC activities.
• Quality and Safety, Compliance
  • Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner; addresses and escalates any potentially unsafe hazards;
    Ensures timely reporting of safety hazards, incidents and near misses using safety reporting tools.
  • Navigates and understands the quality system and escalates issues.
  • Accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.).
  • Performs and documents all transactions and production instructions with accuracy related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, QSR, ISO, Good Manufacturing Practices and other firm policies and procedures.
  • Ensures equipment is in compliance with calibration standards.
  • Conducts out of specification (OOS) and supports non-conformance investigations, reworks, and corrective actions. Serve as a contact for other departments regarding QC related activities.
  • Acts as QC representative in the review of and provides feedback on document changes, including redlines provided by external teams (Development, Operations Scientists, Design Transfer Operations, project teams, etc).
  • Adheres to 95% or above internal training compliance.
  • Maintains complete and accurate records including daily metrics.
• Continuous Improvement
  • Conducts 6S activities, gathers/meets cycle times and…