Lead QA Specialist, cGMP/CSV & NPI

Pinnaql, Inc.; New Jersey; On-site; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. in New Jersey seeks a Specialist QA to support QA program under minimal supervision. The role involves reviewing and approving validation protocols, incident triage, audit support, and leading investigations with a focus on cGMP compliance.

The ideal candidate has advanced degrees or equivalent experience and bilingual proficiency in English and Spanish, with strong communication and leadership skills to drive quality improvements across functions.

Qualifications

• Experience with QA and regulatory compliance in pharmaceutical manufacturing.
• Ability to review and approve validation protocols and reports.
• Strong QA oversight and leadership capabilities in a cGMP environment.

Responsibilities

• Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight to ensure operations for API are manufactured, tested, stored, and managed according to cGMP and applicable regulations.
• Identify, report, and document deviations from procedures per established instructions.
• Assess changes potentially impacting drug substance quality per procedures.
• Ensure production records and testing results are complete and accurately documented.
• Support internal and external audits and inspections as part of the QA team.

Skills

Quality Assurance

Leadership

Communication

Bilingual EN/ES

Attention to detail

Education

Doctorate

Masters + 2 years related experience

Bachelors + 4 years related experience

Tools

CDOCS

Maximo

TrackWise

LIMS

MES/eBRS

SAP

Job description

Validation & Engineering Group, Inc. in New Jersey seeks a Specialist QA to support QA program under minimal supervision. The role involves reviewing and approving validation protocols, incident triage, audit support, and leading investigations with a focus on cGMP compliance.

The ideal candidate has advanced degrees or equivalent experience and bilingual proficiency in English and Spanish, with strong communication and leadership skills to drive quality improvements across functions.