Quality Assurance Associate – Contract / Temp. - San Diego, CA | Biospace
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Quality Assurance Associate – Contract / Temp.

PaxVax, Inc.

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Location:
San Diego, CA
Posted Date:
5/23/2017
Position Type:
Contract
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QA, Quality, Quality Assurance,

Job Description


PaxVax, Inc. has an exciting opportunity for a Quality Assurance (QA) Associate with in-depth experience in drug substance and drug product manufacturing/testing for an 8 months’ contract. Reporting to the Director, Quality Assurance, the QA Associate will provide Quality support for the manufacture and testing of clinical and commercial products. The QA Associate will be accountable for assuring compliance with Quality System and quality oversight at the project level.

Responsibilities:

•   Independently performs Quality review and release of raw materials
•   Review of associated analytical data related to the manufacture of intermediates, drug substances and drug products
•   Review of qualification/stability protocols and stability data
•   Review of equipment/instrument qualification
•   Supports equipment, utility and facility qualification activities, including environmental monitoring
•   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
•   Write, review and approve GMP documentation (SOPs, protocols, reports)
•   Supports implementing process improvements with respect to Quality Assurance
•   Supports external agency and internal audits as required

Requirements


•   BS in Life Sciences and a minimum of 5-7 years of experience in the pharmaceutical / biotech industry
•   Minimum 5 years of experience in Quality Assurance, preferably supporting GMP manufacturing/testing 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 (analytical data, 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 testing and manufacturing problems and suggest resolution of issues
•   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 collaboratively with various work groups
•   Working knowledge of MS Office suite (Word, Power Point, Excel)
•   Experience with electronic documentation systems

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 base