MQA III (Aseptic Process and Cleanroom Behavior)

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:

Fully qualified and capable of executing all responsibilities across MQA Specialist level II and the following:

Cleanroom Oversight & Compliance

• Act as Subject Matter Expert (SME) for aseptic processes and cleanroom behaviors.
• Conduct routine and non-routine audits of cleanroom suites, including personnel, environment, equipment, and materials.
• Observe in-process operations to ensure adherence to aseptic technique and process-specific cGMP procedures.
• Provide real-time feedback and coaching to production operators on aseptic behavior and procedural compliance.
• Perform real-time and retrospective audits to assess operator technique and compliance with cleanroom standards.
• Execute aseptic gowning evaluations and support corrective action plans as needed.

Deviation & Nonconformance Management

• Perform in-process assessments of manufacturing deviations and non-conformances, including risk assessments and immediate corrective actions.
• Support investigations and time-outs by providing technical expertise in aseptic and cleanroom processes.
• Audit cleanroom and pre-cleanroom activities in support of investigations.

Training & Cross-Functional Support

• Act as a compliance resource for other departments, including assistance with deviations, CAPAs, and process-related questions.
• Collaborate with the training department to identify and remediate operator deficiencies.
• Provide support and coaching to ensure operator understanding and application of cGMP requirements.

Media Fill & Sterility Assurance Oversight

• Audit and oversee media fill runs for compliance with aseptic technique and regulatory requirements.

Manufacturing QA Oversight

• Ensure all components and materials issued for manufacturing are approved, within expiry, and appropriate for intended use.
• Verify purity calculations for APIs and ensure proper tracking of bulk powder expiration dates.
• Monitor and verify proper material issuance to batch records and BOMs.
• Oversee cleanroom material stocking, component staging, and bulk mixing processes.

Material & Component Quality Monitoring

• Track trends and escalate issues associated with raw materials, container/closure systems, and in-process components.
• Perform inspections and approvals of reusable components (e.g., glassware, autoclave cycles).

Procedural Compliance & Improvement

• Routinely evaluate procedural adherence and recommend updates to enhance compliance and efficiency.
• Verify completion of required processing steps, including log entries and batch record documentation.
• Audit aseptic cleaning activities and ensure consistency with SOPs and regulatory expectations.

Additional Responsibilities

• Additional tasks inside and outside the cleanroom as required by management.

Education and Experience:

• Minimum of two years in aseptic manufacturing/cGMP experience. At least six months must contain bulk formulation experience.
• Associates degree in a scientific field highly desired.
• Knowledge of computer software highly 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)