EXPANSION Sr. Mfg QA Specialist

Piramal Pharma•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 (QMS) support in accordance with Good Manufacturing Practices (GMP) and site-specific Standard Operating Procedures (SOPs). The role supports compliant manufacturing operations, batch disposition, and product release, with senior-level oversight and technical expertise across environmental monitoring, contamination control, and sterility assurance. The position reports to the Quality Assurance Supervisor and is assigned to the night shift in Lexington. The Senior Manufacturing QA Specialist also serves as a subject matter expert and escalation point for complex manufacturing quality issues, leads investigations and improvement initiatives, and provides technical guidance and mentoring to MQA Specialists. The role participates in client, internal, and regulatory audits and inspections, including FDA and MHRA inspections, and supports responses to audit observations.

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, including in-process QA and environmental monitoring.
Experience working 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.
Ability to communicate effectively verbally and in writing.
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, result review, and accurate 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 inventory management of microbiology materials and environmental monitoring media.
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 under the site QMS.
Serve as a senior MQA subject matter expert in environmental monitoring, contamination control, sterility assurance, and complex manufacturing quality issues.
Support development, implementation, and continuous improvement of 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 quality and process 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.