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Apex Life Sciences

Microbiologist

Post Date:May 17, 2018Type:Full-Time
Start Date:5/17/2018Salary:
Location:US-CA-Costa Mesa Job Reference:715669
Skills:
 

Job Description:

Microbiologist

Leading pharmaceutical company in rapid growth mode is currently seeking Microbiologist at All Levels and Shifts to work within Quality Control, R&D, and Manufacturing/Production departments.

New Grads and Experienced Professionals are welcome to apply!

Responsibilities

A well-regarded and growing biotechnology company with industry leading technology is seeking a Microbiologist for their Los Angeles facility. This is an excellent opportunity to work for an industry leader!

Duties:

  • Perform sterility testing of in-process and final product per compendial methods
  • Establish, validate and sustain environmental monitoring program for company
  • Work with internal and external resources to maintain lab in an optimal state
  • Assist with the validation of rapid release microbiological methods in 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 and develop in-process and final specification system for drug substance and drug product
  • Monitor and trend data
  • Assemble reports on findings from environmental monitoring of company’s cGMP facility, frequently update management on environmental trends and implement corrective action plans when necessary
  • CMO and OTL tracking to complete lot disposition
  • 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
  • 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

Requirements:

  • BS or MS degree in Microbiology or related field
  • Must have advanced knowledge of microbiological techniques including rapid release methods, qualifying environmental monitoring processes, air monitoring, water testing, surface monitoring and genus and species identification
  • Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
  • Must have experience with Quality Control, GMPs, microbiological method development and validation
  • Strong knowledge of GMP, SOPs and QC processes
  • Must have experience identifying and closing OOS’s investigations
  • Strong knowledge of aseptic manufacturing and EM processes
  • Equipment and utility IQ/OQ/PQ/PV
  • Must have working knowledge of MS Word, Excel, Power Point 

EEO Employer

Lab Support is an Equal Opportunity/Affirmative Action Employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.





Contact Information
Apex Life Sciences



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