EXPANSION MQA Specialist

Piramal Pharma Limited; Lexington (SC); On-site; USD 60,000 - 78,000; Full time

Job summary

Piramal Pharma Solutions in Lexington is seeking an Expansion MQA Specialist to perform in-process QA activities, environmental monitoring, and QMS support under GMP conditions.

You will review batch records, assist in audits, maintain calibration of lab instruments, and help drive continuous improvement through trend analysis. This night-shift role requires a Bachelor’s in physical or biological sciences and at least 1 year in QA or environmental monitoring in pharma.

Qualifications

• Bachelor's degree in physical or biological sciences or related field preferred.
• 1 year of Quality assurance or Environmental monitoring experience in a pharmaceutical manufacturing environment.
• Experience in QA Plant support (IPQA/EM), cGMP or FDA regulatory guidelines.
• Knowledge of regulatory requirements (cGMP, OSHA, FDA).
• Proficiency with MS Office (Word, Excel, Outlook, Access).
• Ability to communicate effectively in writing and verbally.
• Ability to read and follow written instructions.
• Detail oriented; sterile manufacturing understanding preferred.
• Technical writing skills preferred.

Responsibilities

• Understand aseptic technique and maintain clean room discipline per cGMPs.
• Perform all in-process QA activities, inspections, labeling and packaging line clearances per SOPs.
• Review batch records and protocols to meet timelines and disposition requirements.
• Perform environmental monitoring of cleanroom areas (air and surfaces).
• Sample and test utilities (water, steam, compressed gases).
• Conduct plate enumeration and document results.
• Assist with cleaning verification sampling and analysis.
• Participate in audits and client site interactions as needed.
• Maintain laboratory instruments and calibrations.
• Analyze environmental monitoring trends to drive improvements and identify issues.
• Support microbiology material inventory for EM media plates.
• Prepare and summarize data; write/review QA and EM SOPs and technical reports.
• Conduct GMP investigations with root-cause analyses and risk assessments.

Skills

QA experience

Environmental monitoring

GMP knowledge

Regulatory awareness

Communication skills

Detail oriented

Education

Bachelor's degree in physical or biological sciences

Tools

Microsoft Office

Job description

EXPANSION MQA Specialist

Job Description

Business: Pharma Solutions

Department: Quality Assurance

Location: Lexington

Job Overview

Reporting to the Quality Supervisor, the primary purpose of the role is to perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).

Reporting Structure

This position reports to the Quality Supervisor.

Shift

Nights

Key Responsibilities

• Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
• Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP's.
• Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
• 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.
• Assist in the performance and documentation for cleaning verification sample collection and analysis.
• Participates in audits and involve 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.
• Participate in Microbiology material inventory control for EM media plates.
• Prepare and summarize data associate with site metrics, write, read, and revise SOP's QA and EM, technical reports.
• Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
• Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.

Qualifications

• Bachelor's Degree in physical or biological sciences or related scientific field preferred.
• 1 years 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

Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com