Quality Assurance Job at Piramal Pharma, USA
Want to start your career in pharmaceutical quality assurance and GMP compliance? The Manufacturing Quality Assurance Specialist role at Piramal Pharma Solutions is an excellent opportunity for candidates interested in the pharma manufacturing industry. This Quality Assurance Job in the USA focuses on in-process quality assurance, environmental monitoring, and GMP compliance. You will work in cleanroom environments and support audits and quality systems. It provides hands-on experience in sterile manufacturing and regulatory practices. This is ideal for candidates looking to build expertise in QA and pharmaceutical operations.
About the Company:
Piramal Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO). The company provides end-to-end services across the drug lifecycle, including drug discovery, development, and commercial manufacturing. With facilities across North America, Europe, and Asia, Piramal supports both innovator and generic pharmaceutical companies worldwide.
Job Details:
- Role: Manufacturing Quality Assurance Specialist
- Location: Lexington, Kentucky, USA
- Department: Quality Assurance
- Job ID: R00000115
- Experience: Minimum 1 year preferred
- Work Type: Full-time
Job Overview:
Reporting to the Quality Supervisor, the primary purpose of the MQA Specialist is to perform In-process Process QA activities, environmental monitoring of facilities and Utility systems, audits, and QMS support according to Good Manufacturing Practices (GMP) and site-specific Standard Operating Procedures (SOP).
Key Responsibilities:
- Develop an understanding of aseptic technique, consistently demonstrate proper cleanroom behaviour, and adhere to cGMPs in this Quality Assurance Job in the USA.
- Perform all In-process QA activities, inspection, labeling, and packaging Line clearances as per the company SOP’s.
- Review executed batch records and executed protocols, and meet the batch disposition timelines as per business requirements.
- Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
- Sampling and lab testing of the utilities, including water, steam, and compressed gases.
- Perform plate enumeration and documentation of the results in the Quality Assurance Job at Piramal Pharma.
- Assist in the performance and documentation for cleaning verification, sample collection, and analysis as a Quality Assurance Specialist.
- Participates in audits and is involved in onsite client interactions as needed by management.
- Maintain laboratory instrumentation required for testing, including calibrations.
- Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends in this Quality Assurance Job in the USA.
- Participate in Microbiology material inventory control for EM media plates.
- Prepare and summarize data associated with site metrics, write, read, and revise SOPs, QA, and EM, and technical reports as a Quality Assurance Specialist.
- Conduct GMP investigations, specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
- Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance, and support Quality management on an as-needed basis in this Quality Assurance Job.
Qualifications Required for this Job:
- Bachelor’s Degree in biological sciences or related scientific field preferred.
- 1 year of Quality assurance or Environmental monitoring experience performing quality-related activities within a pharmaceutical manufacturing environment
- Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA
- Prior knowledge and/or ability to understand and follow job-related regulatory requirements (cGMP, OSHA, FDA)
- Proficiency in the Microsoft Office applications (Word, Excel, Outlook, and Access)
- Demonstrated ability to effectively communicate both verbally and in writing
- Ability to read and follow written instructions
- Detail oriented
- Understanding of sterile manufacturing preferred
- Technical writing skills preferred
Benefits of the Quality Assurance Job:
- Opportunity to work in a global pharmaceutical company
- Hands-on experience in GMP and sterile manufacturing
- Exposure to audits, QMS, and regulatory compliance
- Career growth in quality assurance and pharma operations
- Work in advanced cleanroom and laboratory environments
- Skill development in environmental monitoring and QA systems
