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Quality Assurance Specialist II, Sterile Manufacturing

2 months ago

Chester Springs, Pennsylvania, United States National Resilience Full time
Job Summary

The Quality Technician II, Aseptic Control is a critical role within National Resilience's sterile manufacturing site. This position requires a high degree of autonomy and attention to detail to ensure compliance with regulatory requirements.

Key Responsibilities

  • Prepare and maintain accurate documentation of activities, actions, and results, ensuring adherence to proper documentation practices.

  • Ensure the accuracy and completeness of laboratory notebooks, quality records, and sample receipts.

  • Complete required training and stay up-to-date with Standard Operating Procedures (SOPs) and technical documentation.

  • Perform visual inspections and use the Environmental Monitoring System to collect and analyze samples.

  • Guide others on SOPs, control documents, and work instructions, coordinating activities of support groups.

  • Ensure that laboratory duties are performed in accordance with Current Good Manufacturing Practices (cGMP).

  • Perform regular audits of SOPs and work instructions to ensure compliance.

  • Conduct routine sampling activities and associated data entry.

  • Wear required personal protective equipment (PPE) and gowning, sterile garments as needed.

  • Read and interpret diagrams, drawings, and other schematics.

  • Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance.

  • Provide 24/7 on-call support to others and offer feedback on service and quality issues in a timely manner.

Requirements

  • Prior experience in a pharmaceutical production environment.

  • Ability to effectively understand, read, write, communicate, and follow instructions in the English language.

  • Thorough attention to detail and ability to keep accurate records.

  • Capability to perform mathematical calculations.

Preferred Qualifications

  • High school graduate, vocational school graduate, or equivalent.

  • Working knowledge of MODA, Microsoft applications, SAP, KRONOS.

  • Experience working in a LEAN manufacturing environment.

  • Knowledge of cGMPs and FDA policies/procedures.