MQA III (Aseptic Process and Cleanroom Behavior)

Pine Pharmaceuticals•Tonawanda, NY

18h•Onsite

About The Position

Responsible for the routine oversight of manufacturing operations to ensure compliance with cGMP, Pine Policies and Procedures, and good aseptic technique. This role involves acting as a Subject Matter Expert (SME) for aseptic processes and cleanroom behaviors, conducting audits, providing real-time feedback, and supporting investigations and training.

Requirements

Minimum of two years in aseptic manufacturing/cGMP experience.
At least six months must contain bulk formulation experience.
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)

Nice To Haves

Associates degree in a scientific field highly desired.
Knowledge of computer software highly desired: Microsoft Word, Excel, Sharepoint, Outlook, MasterControl

Responsibilities

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.
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.
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.
Audit and oversee media fill runs for compliance with aseptic technique and regulatory requirements.
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.
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).
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.
Perform additional tasks inside and outside the cleanroom as required by management.