Associate, QA - San Diego, CA | Biospace
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Associate, QA

PaxVax, Inc.

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Location:
San Diego, CA
Posted Date:
10/25/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Compliance, Pharmaceutical, QA, Quality Assurance,

Job Description

PaxVax is seeking a Quality Assurance (QA) Associate with in depth experience in drug substance and drug product manufacturing. Reporting to the Director, Quality Assurance, the QA Associate will provide Quality support for the manufacture and testing of non-clinical and clinical products. The QA Associate will be accountable for assuring compliance with Quality Systems, quality oversight at the project level and generation of metrics to drive continuous improvement, while assuring the quality of materials manufactured and data generated.

Responsibilities:
•   Review of master batch records
•   Review and approval of executed batch records
•   Support the disposition of intermediates, drug substances and drug products
•   Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments
•   Quality monitoring of in-house and CMO manufacturing operations
•   Review of  associated analytical data related to the manufacture of  intermediates, drug substances and drug products
•   Responsible for the review of  qualification/stability protocols and stability data
•   Independently performs Quality  review and release of  raw materials
•   Supports equipment and  instrument qualification activities
•   Write, review and approve GMP documentation (SOPs, protocols, reports)
•   Aid in implementing process improvements with respect to Quality Assurance
•   Supports external agency and internal audits as required

Requirements

•   BS in Biological sciences, Chemistry or relevant discipline
•   A minimum of 5 years  relevant  experience  in the pharmaceutical/ biotech industry
•   4 + years of increasing responsibility and relevant QA experience in a pharmaceutical/biotechnology environment supporting GMP manufacturing of biologics for clinical and commercial use
•   Working knowledge of cGMP principles with respect to FDA and EMA regulations
•   Experience in reviewing and approving cGMP related documents (batch records, test data packages, equipment qualification, SOPs, protocols, reports)
•   Experience in deviations,  investigations, determining root cause, and developing corrective action plans
•   Knowledge of drug development process
•   Ability and demonstrated experience to identify technical manufacturing problems and suggest resolution of issues
•   Ability to independently analyze/resolve moderate issues.
•   Demonstrated initiative and accountability in a fast paced environment.
•   Demonstrated proficiency in application of QA principles, concepts, industry practices and standards
•   Problem solving skills, effective written and verbal communication skills
•   Excellent documentation skills and attention to detail
•   Highly organized and ability to manage multiple priorities
•   Ability to work independently and with various work groups
•   Working knowledge of MS Office suite (Word, Power Point, Excel)

Physical Demands/work environment:
•   Some evening/weekend work may be required to support manufacturing on occasion
•   Ability to work in cleanroom environment
•   Ability to sit  for a long periods of time; majority of work is computer based

Travel:
•   None