QA Manager: Batch Release & Complaints (Hybrid, San Diego)

ARS Pharmaceuticals, Inc.; San Diego (CA); Hybride; USD 145 000 - 185 000; Plein temps

Avantages offerts par ce poste

Equity

401k matching

Medical, Dental & Vision

Résumé du poste

ARS Pharmaceuticals, Inc. in San Diego seeks a hands-on Manager/Senior Manager Quality Assurance to own batch disposition, product complaint management, and CMO QA oversight.

The role collaborates with Regulatory, Supply Chain, and Medical Affairs to ensure cGMP compliance and timely release of products manufactured at CMOs. Responsibilities include reviewing batch records, closing deviations, leading CAPAs, and supporting audits and inspections.

Qualifications

• Bachelor's degree in science plus 6+ years QA experience.
• Hands-on batch record review and lot disposition for pharma products.
• Experience managing product complaints, deviations, and CAPAs.
• Working knowledge of cGMP, ICH guidelines, FDA expectations.

Responsabilités

• Review batch records, packaging records, and COAs from CMOs for accuracy and cGMP.
• Close deviations, OOS/OOT results, and change controls before release.
• Prepare lot disposition packages and act as QA approver per delegation.
• Review master batch records and specifications for products.
• Track batch release timelines and coordinate with Supply Chain.

Connaissances

QA experience

Batch record review

Deviations & CAPAs

cGMP knowledge

Regulatory liaison

Formation

Bachelor's degree in chemistry, biology, pharmacy, engineering, or related science

Outils

CMO oversight tools

QMS software (Veeva Vault)

MasterControl

Description du poste

ARS Pharmaceuticals, Inc. in San Diego seeks a hands-on Manager/Senior Manager Quality Assurance to own batch disposition, product complaint management, and CMO QA oversight.

The role collaborates with Regulatory, Supply Chain, and Medical Affairs to ensure cGMP compliance and timely release of products manufactured at CMOs. Responsibilities include reviewing batch records, closing deviations, leading CAPAs, and supporting audits and inspections.