Senior Quality Assurance Scientist

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

The resources for this opportunity must meet the following minimum requirements in order to be considered:

Qualifications and Required Knowledge/Skills

• Bachelor’s degree in science (e.g., Chemistry, Biology, Microbiology, Pharmacy) or Engineering, with six (6) years of experience in a role exercising GMP responsibilities in the pharmaceutical industry.
• Three to five 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 the ability to interpret and apply them for intended use.

Demonstrable skills in:

• Problem solving
• Critical thinking
• Learning capability
• Analytical thinking

Attention to detail in review of GMP documents (e.g., Deviation Reports (manual/electronic), SOPs, CAPAs, Logbooks, Reports, Batch Records)

Ability to identify which matters must be dealt with a sense of urgency; ability to work under fast-paced conditions and to quickly identify when Subject Matter Experts and/or Senior Management must be involved.

Self-starter with interpersonal skills and the ability to interact with people at all levels.

Fully bilingual (Spanish/English) with excellent written and verbal communication skills.

Proficient knowledge of computer systems (Microsoft Office, etc.) and applications such as Trackwise/Infinity and SAP.

Preferred Background

Knowledge and in-depth experience in various GMP processes (e.g., Change Control, Investigations), plus Lean/Six Sigma training or certifications.

Weil Group is proud to be an Equal Employment Opportunity Employer.