EXPANSION MQA Specialist

Piramal Pharma Ltd•Lexington, KY

11d

About The Position

The EXPANSION MQA Specialist works in Pharma Solutions’ Quality Assurance department in Lexington. Reporting to the Quality Supervisor, the role performs in-process process QA 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 operates on the night shift. The role includes conducting in-process QA inspections and line clearances, reviewing batch records and protocols, monitoring classified cleanrooms, sampling and testing utilities, supporting cleaning verification, maintaining laboratory instruments and environmental monitoring records, and contributing to audits and client interactions. The specialist also supports GMP investigations, including root cause analyses, risk assessments, and impact evaluations, and follows applicable health, safety, and environmental requirements.

Requirements

At least 1 year of Quality Assurance or environmental monitoring experience performing quality-related activities in a pharmaceutical manufacturing environment.
Previous experience in QA plant support, such as in-process QA or environmental monitoring, and 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.
Attention to detail.

Nice To Haves

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

Responsibilities

Learn and apply aseptic technique, maintain proper cleanroom behavior, and adhere to cGMPs.
Perform in-process QA activities, inspections, labeling, and packaging line clearances according to company SOPs.
Review executed batch records and protocols and meet batch disposition timelines.
Perform environmental monitoring of classified cleanroom areas, including viable surface and air monitoring and non-viable air monitoring.
Sample and conduct laboratory testing of utilities, including water, steam, and compressed gases.
Enumerate plates and document results.
Assist with collecting and analyzing cleaning verification samples and documenting the work.
Participate in audits and onsite client interactions as requested by management.
Maintain laboratory instrumentation used for testing, including calibrations.
Help maintain environmental monitoring trend data to support continuous improvement and identify trends.
Participate in inventory control for environmental monitoring media plates.
Prepare and summarize site metrics data, and write, read, and revise QA and environmental monitoring SOPs and technical reports.
Conduct GMP investigations, including root cause analyses, risk assessments, and impact evaluations, in accordance with PPS QMS systems.
Follow applicable health, safety, and environmental regulations, policies, and procedures, and support Quality management as needed.