Senior QA Scientist — GMP & CAPA Expert

Weil Group, Inc; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. seeks a GMP Quality Systems professional with a strong track record in investigations, CAPA, and change control. The role requires six years in pharmaceutical GMP settings, plus expertise in cGMPs, FDA/EU regulations, and manufacturing operations for parenteral products.

Fluency in Spanish and English is essential. The successful candidate will review GMP documents with meticulous attention to detail, work under pressure, and coordinate with SMEs and senior leaders as needed.

Qualifications

• Bachelor’s degree in science (e.g., Chemistry, Biology, Microbiology, Pharmacy) or Engineering with six (6) years GMP experience in pharma.
• 3–5 years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
• Knowledge of manufacturing operations of Parenteral Products Manufacturing.
• In-depth knowledge of cGMPs, FDA and EU regulations, and ability to interpret and apply them for intended use.
• Attention to detail in review of GMP documents (Deviation Reports, SOPs, CAPAs, Logbooks, Reports, Batch Records).
• Ability to identify which matters must be dealt with urgently; work under fast-paced conditions and escalate to SMEs/Senior Management as needed.
• Self-starter with interpersonal skills and ability to interact with people at all levels.
• Fully bilingual (Spanish/English) with excellent written and verbal communication; Proficient knowledge of Microsoft Office and TrackWise/Infinity and SAP.

Skills

Problem solving

Critical thinking

Learning capability

Analytical thinking

Attention to detail

Urgency judgment

Self-starter

Interpersonal skills

Bilingual Spanish/English

Communication skills

Education

Bachelor’s degree in science or engineering

Tools

TrackWise

Infinity

SAP

MS Office

Job description

Weil Group, Inc. seeks a GMP Quality Systems professional with a strong track record in investigations, CAPA, and change control. The role requires six years in pharmaceutical GMP settings, plus expertise in cGMPs, FDA/EU regulations, and manufacturing operations for parenteral products.

Fluency in Spanish and English is essential. The successful candidate will review GMP documents with meticulous attention to detail, work under pressure, and coordinate with SMEs and senior leaders as needed.