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Bachem · 1 month ago

Quality Assurance Specialist II

Vista, CA

Full-time

Onsite

Mid Level

$72K/yr - $99K/yr

3+ years exp

Bachem is a company focused on ensuring compliance with FDA and international regulatory requirements for drug substances. The QA Specialist II will manage quality assurance activities, support audits, and maintain GMP documentation to ensure product quality and regulatory compliance.

Chemical

Responsibilities

Performs production room, dispensary and shipment clearance verifications, as required

Revises established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned

Manages GMP documentation and their workflows as required by the department

Verify scans of BPRs, chromatograms, etc. for accuracy and ensure documents are boxed, labeled correctly for archiving

Coordinate, review and approval of quality events

Training of new hires

Provides support to regulatory, customer, and internal audits

Drives continuous improvements and represents QA in process improvement project teams

Implements and maintains Quality Management System

Scan, verify and archive GMP records (internal and external)

Review and/or approval of monitoring / trending data

Represent QA in project teams (e.g. – harmonization of systems / processes across Bachem sites, implementation of new systems / processes)

Qualification

GMP manufacturing experienceQuality Assurance experienceCGMPFDA regulationsInternal auditing experienceQuality Management SystemsExperience in ISO 7ISO 8Proficient in Microsoft OfficeEffective communicationProblem-solving skillsOrganizational skills