QC Scientist II, Microbiology

Employer
Bachem
Location
Vista, CA, US
Posted
Sep 07, 2020
Ref
609395701
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Your Responsibilities

The QC Scientist II, Microbiology will manage and execute the environmental monitoring program, water and critical utilities monitoring program. Other duties include performing, QC documentation including lab notebooks and reports and related GMP activities .

Your Tasks
  • Perform necessary environmental monitoring procedures to include water sampling, viable and non-viable air sampling and viable surface monitoring
  • General upkeep of microbiology laboratory including monitoring of temperatures for incubators and storage refrigerators
  • Perform necessary testing for approval of vendors and qualification of necessary media used in the microbiology laboratory
  • Maintain and support the cleaning verification program by performing Total Organic Carbon testing
  • Trend microbiology data and report back to management and QA to ensure systems are within trend
  • Perform endotoxin testing for final lyophilized peptide products. The kinetic and gel clot method will both be employed
  • Write/revise standard operating procedures, and other related GMP documentation as related to the job function as necessary
  • Maintain GMP areas to ensure compliance for all requirements for control of materials. This includes cleanliness and organization
  • Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
  • Operate, maintain and ensure calibration of equipment including, chart recorders, thermometers, analytical balance, pipette and other related equipment in microbiology lab and the GMP facility as required by job function
  • Investigate any deviation or out of specification as necessary related to Quality Control work performed as instructed by supervisor
  • Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste


Your Profile
  • Bachelor's Degree in Life Sciences
  • Minimum 4 years' experience in a GMP environment specializing in pharmaceutical or biotech industry
  • Use of analytical techniques / instruments, such as TOC, Endotoxin, Conductivity, etc., and computer skills
  • Develop and maintain environmental tracking and trending programs
  • Knowledge of ICH Q1 and ICH Q7, cGMP and FDA regulations
  • Experience working in a clean rooms (ISO 7 and/or ISO 8)
  • Ability to effectively organize, multitask, and work in a fast-paced environment
  • Excellent written and oral communications skills
  • Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
  • Exhibit professional interpersonal skills
  • Communicate effectively and ability to function well in a team environment
  • Exhibit detail oriented documentation skills
  • Ability to work independently and manage one's time
  • Basic computer knowledge, including Microsoft Word and Excel
  • Coordinate sampling and testing in collaboration with Quality Control and Production
  • Ability to convey to customers and regulatory agencies topics regarding micro-biology processes
  • Flexibility of working hours based on business needs, may include some nights and occasional weekends


Preferred:

Experience with Minitab and/or other statistical software



We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you

are looking for a new challenge and want to join a motivated team in an internationally renowned

company, you should seize this opportunity.

Nearest Major Market: San Diego