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QA Manager

Company: Astrix
Location: Vista
Posted on: January 13, 2022

Job Description:

The Quality Assurance Manager is responsible for operations related Quality Assurance activities including; the manufacturing floor quality oversight, GMP documentation, batch record review and batch release.

Your Tasks:
Oversee and support implementation of electronic document control modules (Master Control) and ERP system (SAP)
GMP compliance improvements
Writing new and revising current standard operating procedures (SOPs), specifications, etc.
Auditing Production, Materials Management, and Quality Control functions
Writing internal audit reports
Support customer & regulatory audits. Responding to audit observations
Reviewing all GMP documentation, including BPRs, SOPs, Specifications, Protocol, and Reports
Reviewing trending data, Change Controls, Deviations, and CAPA's
Problem resolutions with GMP systems

Qualifications:
Bachelor's Degree in Chemistry or Biochemistry
Minimum of 5 years' experience in a GMP/regulated industry
Minimum of 3 years in QA management position
Experience in GMP manufacturing environment, Quality Assurance, Quality Control
Experience with 21 CFR Parts 110, 111, 210, 211, ICH Q7
Experience with GMP document control
Experience in both internal and external auditing
Ability to work with regulatory agencies
Strong supervisory skills and technical writing skills
Excellent written and oral communication skills
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one's time
Communicate effectively and ability to function well in a team environment

EXCELLENT benefits!
Health insurance- Aetna, PPO, $25/month. $50 deductible.
Sick time, PTO
Vacation- 2 weeks.
11 paid holidays

Keywords: Astrix, Vista , QA Manager, Executive , Vista, California

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