EXPANSION Sr. Mfg QA Specialist

Piramal Pharma Ltd•Lexington, KY

About The Position

The Senior Manufacturing QA Specialist performs in-process quality assurance activities, environmental monitoring of facilities and utility systems, audits, and Quality Management System support in accordance with Good Manufacturing Practices (GMP) and site-specific Standard Operating Procedures (SOPs). The position is part of the Quality Assurance department at Piramal Pharma Solutions in Lexington and reports to the Quality Assurance Supervisor. The shift is nights. The role provides senior QA oversight and technical expertise in manufacturing quality, Environmental Monitoring, Contamination Control, and Sterility Assurance. It supports compliant batch disposition and product release, audit readiness, investigations and CAPAs, and continuous improvement of QA, QMS, environmental monitoring, and contamination-control programs. The specialist also provides technical guidance and mentoring to MQA Specialists and participates in client and site quality activities.

Requirements

At least 4 years of Quality Assurance or Environmental Monitoring experience performing quality-related activities in a pharmaceutical manufacturing environment.
Previous experience in QA Plant Support (IPQA/EM), under strict regulatory guidelines, cGMP, or FDA requirements.
Knowledge of, or ability to understand and follow, job-related regulatory requirements, including cGMP, OSHA, and FDA requirements.
Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Access.
Effective verbal and written communication skills.
Ability to read and follow written instructions.
Detail-oriented.

Nice To Haves

Bachelor's degree in physical or biological sciences or a related scientific field preferred.
Understanding of sterile manufacturing preferred.
Technical writing skills preferred.

Responsibilities

Maintain compliance with site procedures and demonstrate knowledge of aseptic processing, cleanroom behavior, and cGMP requirements.
Perform and oversee in-process QA activities, including inspections, labeling, packaging, and line clearances under approved SOPs.
Review executed batch records, protocols, and supporting documentation to support timely, compliant batch disposition.
Perform and provide technical oversight of environmental monitoring in classified areas, including viable surface and air monitoring and non-viable air monitoring.
Sample and test site utilities, including water, steam, and compressed gases, as applicable.
Perform microbiological testing, including plate enumeration, results review, and documentation.
Support cleaning verification through sample collection, testing, review, and documentation.
Maintain laboratory instrumentation and ensure required calibration and qualification activities are completed.
Evaluate environmental monitoring and quality trends, identify potential adverse trends, and initiate risk-based actions and continuous improvement initiatives.
Support microbiology material and environmental monitoring media inventory management.
Prepare, review, and revise SOPs, technical reports, risk assessments, site metrics, and other QA and environmental monitoring documentation.
Lead complex GMP investigations, including root-cause analysis, product impact assessments, risk assessments, and CAPA development in accordance with the site QMS.
Serve as a Senior MQA subject matter expert for Environmental Monitoring, Contamination Control, Sterility Assurance, and complex manufacturing quality issues.
Support development, implementation, and continuous improvement of the site's Environmental Monitoring and Contamination Control programs, including related risk assessments and technical reports.
Provide senior QA oversight and coordinate quality activities supporting batch disposition and product release.
Represent MQA during client, internal, and regulatory audits, including FDA and MHRA inspections, and support responses to audit observations.
Provide technical guidance, coaching, and mentoring to MQA Specialists and act as an escalation point for complex quality and compliance matters.
Lead and support improvement initiatives involving QA processes, QMS performance, environmental monitoring, contamination control, and manufacturing quality.
Perform material disposition and related activities in SAP, ensuring accurate documentation and timely disposition.
Participate in client interactions, investigations, technical discussions, and other site quality activities as required by management.
Ensure compliance with applicable cGMP, regulatory, health, safety, environmental, and company requirements.