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)