Quality Assurance Associate II

BioPhase Solutions specializes in placing the top talented professionals in the leading Biotechnology and Pharmaceutical companies in Los Angeles and Orange County.  We are currently recruiting for a Quality Assurance Associate to work for a company in the Orange County area.

 

 

The Quality Assurance Associate II is responsible for the organization, and maintenance of the system for controlling the generation and revision of all controlled documents for the company.  Under the direction of the Director, QA, he/she maintains centralization of documents and assures the document control system is adhered to.

 

Job Requirements

 Reviewing, updating and organizing documents prior to lot disposition. 

 Assuring revision levels on documents are correct when used for manufacture of product and QC testing at the beginning (raw material), intermediate (in process), and final stages of production (Final Product). 

 Reviewing Batch Records, RMSs, QC test reports, Oven Autoclave Cycles, Calibration Records, and Environmental Monitoring Records for lot disposition according to specifications.

 Assist in maintaining Training Records of Employees.

 Track employee training, compile trend NCMRs & DRs, CAPAs on materials, processes and products to ensure that company quality standards are met.

 Assist in the development, implementation and maintenance of  quality assurance systems and activities in support of manufacturing.

 Ensure that assessment, control, inspection and sampling of raw materials, packaging materials, in-process products and finished goods is performed consistent with cGMP,  and company standards.

 Verify labels generated by Quality Control Unit for raw materials and final product vials.

 Assist with several other Quality Assurance and Document Control functions.

 Maintain Good Manufacturing Practice (GMP) at company. 

 Other duties as assigned.

 

 

Qualifications

 

BS/BA in field of chemistry, microbiology, biology, biochemistry, plus 2 years experience or Associate Degree plus 3 to 5 years related experience within a cGMP regulated environment.  Additional technical experience in an area allied with cGMP Quality, such as technical services, laboratory operations, manufacturing operations, desirable. The amount of technical experience required will vary based on the candidate’s strength in quality.

 

BioPhase Solutions – the right opportunities with the right companies

Our goal is to make a positive impact to science by matching candidate's skill sets with company's needs. Our staff has a reputation for excellence in the industry by developing professional relationships with the finest pharmaceutical and biotechnology companies in the Los Angeles area. For immediate response please forward your resume to chris@biophaseinc.com

Please visit our website to view all our current openings.


www.biophaseinc.com