QA Specialist, Batch Records & Compliance

Aerogen Pharma; San Mateo (CA); On-site; USD 88,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Retirement

Life Insurance

Paid Time Off

Global EAP

Short-Term Disability

FMLA Benefits

Job summary

Aerogen Pharma in San Mateo, CA, is seeking a Quality Specialist to support Quality Operations across batch record review, data validation, vendor management and QMS improvements. You will ensure GMP compliance, review manufacturing and labeling records, and assist with audits and CAPAs in a regulated environment.

Ideal candidates hold a bachelor’s degree in life sciences and have 3+ years in GMP/QA, with experience reviewing batch records and overseeing CMOs or suppliers.

Qualifications

• Strong working knowledge of pharmaceutical cGMP, Good Documentation Practices, ALCOA+ data‑integrity principles, and applicable regulatory requirements.
• Ability to review manufacturing, packaging, labeling, cleaning, and testing records for accuracy, completeness, compliance, and lot‑disposition readiness.
• Experience supporting deviations, nonconformances, root‑cause investigations, CAPAs, change controls, audits, and regulatory inspections.
• Clear written and verbal communication skills, with the ability to document observations and communicate requirements in an inspection‑ready manner.

Responsibilities

• Batch Record Review: Review manufacturing, packaging, labeling, and related records for accuracy and compliance.
• Data Review & Validation: Validate batch data and support internal/external inspections.
• Vendor Management: Oversee CMOs and suppliers and monitor quality‑agreement compliance.
• QMS Support: Ensure GMP processes are reflected in the QMS and assist training activities.

Skills

cGMP knowledge

QA oversight

Documentation integrity

Vendor management

Education

Bachelor's degree in pharmacy or life sciences

Tools

Veeva

TrackWise

MasterControl

SAP

Oracle

Job description

Aerogen Pharma in San Mateo, CA, is seeking a Quality Specialist to support Quality Operations across batch record review, data validation, vendor management and QMS improvements. You will ensure GMP compliance, review manufacturing and labeling records, and assist with audits and CAPAs in a regulated environment.

Ideal candidates hold a bachelor’s degree in life sciences and have 3+ years in GMP/QA, with experience reviewing batch records and overseeing CMOs or suppliers.