Senior Manufacturing QA Specialist — Night Shift

Piramal Pharma Limited; Lexington (SC); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, SC is seeking a Sr. Manufacturing QA Specialist to ensure regulatory compliance during manufacturing, testing, warehousing and distribution of pharmaceutical products.

Reporting to QA Supervisor, this role conducts on-floor QA oversight, reviews batch records, supports audits, and drives continuous improvement. A background in cGMP and FDA regulations, plus 3+ years in pharmaceutical QA, is required.

Qualifications

• 3+ years of QA experience in pharmaceutical manufacturing.
• Experience with cGMP or FDA regulations.
• Strong written and verbal communication skills.
• Detail oriented with ability to read and follow written instructions.
• Proficiency with Microsoft Office.
• Experience with sterile manufacturing is preferred.

Responsibilities

• Write, read and revise technical reports.
• Train and support staff on QA responsibilities.
• Review batch records and protocols and address issues.
• Prepare and summarize data for site metrics.
• Assist QA leadership in process mapping and system analysis.
• Review pest control, calibration, HEPA certification, logbooks, and work orders.
• Provide QA oversight on the floor during manufacturing.
• Participate in audits and client interactions.
• Represent Quality during meetings, audits and investigations.
• Execute assigned training and development plans.
• Troubleshoot GMP issues.
• Provide SME support and lead cross-functional projects.

Skills

Communication skills

Attention to detail

Technical writing

Education

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

Tools

MS Office

Job description

Piramal Pharma Solutions in Lexington, SC is seeking a Sr. Manufacturing QA Specialist to ensure regulatory compliance during manufacturing, testing, warehousing and distribution of pharmaceutical products.

Reporting to QA Supervisor, this role conducts on-floor QA oversight, reviews batch records, supports audits, and drives continuous improvement. A background in cGMP and FDA regulations, plus 3+ years in pharmaceutical QA, is required.