EXPANSION MQA Specialist

Piramal Pharma Limited; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY is seeking an EXPANSION MQA Specialist to support in-process QA, environmental monitoring, and GMP compliance. Reporting to the Quality Supervisor, you will perform QA activities, review batch records, and participate in audits.

The ideal candidate holds a Bachelor’s degree in physical or biological sciences, at least 1 year QA or EM experience in pharma, and proficiency with MS Office; strong communication, attention to detail, and technical writing

Qualifications

• Bachelor's degree in physical or biological sciences or related field.
• 1 year of QA or Environmental monitoring experience in pharma.
• Experience in QA Plant support (IPQA/EM) with cGMP or FDA.
• Proficiency with Microsoft Office applications.
• Strong communication skills, both written and verbal.
• Ability to read and follow written instructions.
• Detail oriented; sterile manufacturing knowledge preferred.
• Technical writing skills preferred.

Responsibilities

• Acquire understanding of aseptic technique and maintain clean room discipline under cGMP.
• Perform In-process QA activities, inspection, labeling and packaging clearances per SOPs.
• Review batch records and protocols, meet disposition timelines.
• Environmental monitoring of cleanroom areas (air and surfaces).
• Sampling and testing of utilities (water, steam, compressed gases).
• Plate enumeration and documentation of results.
• Assist in cleaning verification sample collection and analysis.
• Participate in audits and client interactions as needed.
• Maintain laboratory instrumentation and calibrations.
• Maintain EM trend data for continuous improvements.
• Inventory control for EM media plates; site metrics data preparation.
• Prepare and summarize QA/EM SOPs and technical reports.
• Conduct GMP investigations: root cause analyses, risk assessments, impact evaluations.
• Adhere to regulations and support quality management.

Skills

QA experience

Environmental monitoring

Regulatory compliance

Technical writing

MS Office

Communication skills

Attention to detail

Education

Bachelor's degree in physical or biological sciences or related field

Tools

Microsoft Office

Job description

**Division**Piramal Pharma SolutionsPiramal 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.comJob TitleEXPANSION MQA SpecialistJob DescriptionBusiness: 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