Senior GMP QA Specialist Night Shift

piramalpharma; Lexington (VA); On-site; USD 70,000 - 100,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, VA is seeking a Sr. Mfg QA Specialist to ensure compliance with cGMP and FDA regulations across manufacturing, testing, warehousing, and distribution. You will oversee quality activities on the plant floor and support audits and client interactions.

The role requires strong technical writing, great attention to detail, and experience in pharmaceutical manufacturing. Nights shift provides exposure to challenging processes and cross-functional collaboration.

Qualifications

• 3+ years of QA experience in pharmaceutical manufacturing.
• Must have knowledge of cGMP or FDA regulations.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook and Access).
• Demonstrated ability to communicate effectively in writing and verbally.
• Detail oriented; strong technical writing skills.
• Experience with sterile manufacturing is preferred.

Responsibilities

• Write, read and revise technical reports.
• Train and support staff regarding QA responsibilities.
• Review batch records and protocols and coordinate with departments to address issues.
• Prepare and summarize data associated with site metrics.
• Assist QA Leadership in process mapping and system analysis.
• Review pest control, calibration, HEPA certification, logbooks, and work order documentation.
• Perform on-the-floor QA oversight activities and product inspections.
• Participate in audits and self-inspections; represent QA in client meetings.

Skills

QA experience

Regulatory knowledge

Attention to detail

Technical writing

Education

Bachelor's degree in physical or biological sciences

High school diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

Outlook

Access

Job description

Piramal Pharma Solutions in Lexington, VA is seeking a Sr. Mfg QA Specialist to ensure compliance with cGMP and FDA regulations across manufacturing, testing, warehousing, and distribution. You will oversee quality activities on the plant floor and support audits and client interactions.

The role requires strong technical writing, great attention to detail, and experience in pharmaceutical manufacturing. Nights shift provides exposure to challenging processes and cross-functional collaboration.