Quality Control Scientist - Los Angeles, CA | Biospace
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Quality Control Scientist

Apex Life Sciences

Location:
Los Angeles, CA
Posted Date:
3/9/2017
Position Type:
Contract, Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Assay, Assay Development, Biochemistry, Biomarker, Biotechnology, Cancer, Cell Biology, Cell Culture, Cytometry, Elisa, Flow Cytometry, Molecular Biology, PCR,

Job Description

A well-regarded company focusing on patient therapies is seeking a Quality Control Scientist to join their team. This is a great opportunity to work for an industry leader!

DUTIES AND RESPONSIBILITIES:
•   Provide Quality Control testing of clinical manufacturing of final drug product.
•   Stage appropriate validation of bioanalytical methods for cell therapy products.
•   Responsible for raw material testing, in-process and final product testing.
•   Qualification of QC instrumentation.
•   Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to a contract-testing lab.  
•   Validation of methods will be phase appropriate.
•   Establish specifications and testing process of raw materials.
•    Develop in-process and final specification system for drug substance and drug product
•   Work with internal and external resources to maintain lab in an optimal state.
•   Monitor and trend data
1.   Assemble reports on findings from environmental monitoring of  cGMP facility.  Frequently update management on environmental trends.  Implement corrective action plans when necessary.  
2.   CMO and OTL tracking to complete lot disposition
3.   Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release
•   Assist in the preparation of dossiers and data packages for interactions between company and Regulatory agencies.  Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
•   Develop, revise and review SOPs, qualification/validation protocols and reports.
•   Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.  Provide updates at daily and weekly meetings.
•   Monitor the GMP systems currently in place to ensure compliance with documented policies.
•   Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
•   Gather metric information for use in continuous improvement of areas of responsibility
•   Perform other duties as required

Requirements

•   Required:  BS with 6-7 years, MS with 4 – 5 years of Quality Control experience or PhD molecular biologist or biochemist preferred with 1-2 years of Quality Control experience.
•   MUST be well versed in various analytical techniques such as flow cytometry and/or FACS.
•   Additional skills that  are ideal include: ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals
•   Quality Control, GMPs, bioanalytical method development and validation.
•   Strong knowledge of GMP, SOPs and quality control processes.  
•   Identifying, writing evaluating and closing OOS’s and investigations.
•   Equipment and utility IQ/OQ/PQ/PV.
•   Proficient in MS Word, Excel, Power Point and other applications.
•   Strong written and verbal communication skills.
•   Ability to communicate and work independently with scientific/technical personnel.
•   Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
•   Preferred:  Experience in the biotech and/or pharmaceutical industry.