MQA Specialist II- Cleanroom

Position Summary:

Responsible for the routine oversight of manufacturing operations to ensure compliance with cGMP, Pine Policies and Procedures, and good aseptic technique.

Essential Functions:

Cleanroom Oversight & Aseptic Compliance

• Conduct routine auditing of cleanroom suites, including personnel practices, equipment, environment, and materials.
• Perform real-time and retrospective assessments to ensure adherence to cGMP and aseptic techniques.
• Observe and verify execution of manufacturing activities as documented in batch records.
• Serve as an expert reference for aseptic operators, providing real-time verification of compliance with cGMP and internal procedures.
• Audit media fill process runs to verify aseptic technique and regulatory adherence.
• Monitor pre-cleanroom and cleanroom activities to support investigations and process improvement.

Deviation Management & Investigations

• Conduct in-process assessments of deviations and non-conformances, including immediate risk evaluation and remediation.
• Support cross-departmental investigations by providing information on aseptic and cleanroom processes.
• Escalate observed deficiencies to appropriate supervisory staff with suggested corrective actions.

Training & Operator Support

• Coach production operators on aseptic behavior, proper gowning, and procedural adherence.
• Collaborate with the Training Department to address skill gaps and reinforce best practices.
• Execute routine and non-routine gowning evaluations to assess operator qualification.

Material & Component Quality Oversight

• Ensure components issued to batches are approved and within expiration limits.
• Monitor and verify raw materials and in-process components for suitability and integrity, including:
  • Container/closure system issues
  • Faulty components
• Approve re-usable components (e.g., glassware, autoclave cycles) before use.

Manufacturing QA Daily Functions

• Provide oversight of materials entering cleanrooms to ensure compliance and suitability.
• Verify that issued materials align with production requirements and batch specifications.

Procedural Adherence & Documentation

• Audit aseptic cleaning activities for consistency and effectiveness.
• Regularly evaluate procedural adherence and recommend updates for improved efficiency and compliance.

Regulatory Compliance & Support

• Support changes dictated by SOP or policy updates to ensure compliance with cGMP and regulatory standards.
• Additional tasks inside and outside the cleanroom as required by management.

Education and Experience:

• Minimum of one year in aseptic manufacturing/cGMP experience
• Knowledge of computer software desired: Microsoft Word, Excel, Sharepoint, Outlook, MasterControl

Knowledge, Skills and Abilities:

• Strict attention to detail
• Quality-based mindset
• Ability to identify and address deviations from policy and procedure
• Ability to perform risk-based assessment of events
• Strong communication skills and ability to advise operators for corrections when deviations are identified
• Excellent time management and ability to balance multiple responsibilities within the confines of one shift
• Ability to work independently and as a team
• Ability to identify process or procedure flaws and propose pathways to improvement (i.e., problem solving skills)

Salary : $22 - $26