Quality Control Analyst I

Framingham, MA

Posted: 09/19/2019 Industry: Biotech/R&D/Science Job Number: 49564

Duties: 

Quality Control Microbiology supports manufacturing activities at Framingham Campus by detecting, quantifying, and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environmental where the manufacturing process is executed.  It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the  end product  will meet the pre-defined standards for safety, purity, identity and effectiveness.  

Contribute to general operations and testing of the QC Microbiology laboratory.  Work independently and under general supervision to conduct microbiological routine testing of environmental, critical utility, raw materials, in-process, validation samples and final products in accordance with SOPs and cGMP regulations.  Review laboratory assay documentation for accuracy and timeliness, evaluation preliminary results; aid in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.  

Core  Responsibilities:
  • Collect  and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory  duties. 
  • Perform  Water, Steam, and Critical Utility collection as well as associated  testing. 
  • Perform  Biological Indicator  Testing. 
  • Perform  Environmental  Monitoring. 
  • Perform  Endotoxin Testing (Gel Clot and Kinetic Turbidimetric). 
  • Perform Bioburden Testing of In-Process products, buffers, and  water. 
  • Receive  manufacturing samples into the QC Lab as well as sample retain  disposal. 
  • Troubleshoot  assay and instrument problems with Laboratory  Supervisor. 
  • Enter  and review data in  LIMS. 
  • Perform  safety and operational lab  audit. 
  • Perform  general maintenance of lab  equipment. 
  • Participate  in writing and revisions SOPs,  protocols. 
  • Assist  in the development and optimization of testing  methods. 
  • Maintain logbooks related to inventory and equipment. 
  • Ensure  labs are clean and safe (in compliance with cGMP) and properly  stocked. 
  • Make  detailed observations in support of Alert, Action, and OOS result  investigations. 
  • Participate  in the qualification of equipment, methods, and  processes. 
  • Participate  and perform special studies & projects assigned to  microbiology. 
  • Perform  ELISA  testing. 
  • Perform other additional  job-related  duties as required. 
  • Perform  plate reading, streaking, gram staining, microbial  identification. 
  • Perform  routine Quality Control testing of in-process and final products in a cGMP lab for  release. 
  • Practice safe work habits and adhere to safety procedures and  guidelines. 
  • Provide  training to less experienced  staff. 
  • Participate in authoring complex and explicit documentation (protocols and technical reports) 
  • Involvement in equipment or facility qualifications (IQ/OQ/PQ) and method validation.  

* Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs. 

Skills: 
  • Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and  procedures. 
  • Being  honest and treating people with respect and  courtesy. 
  • Constantly striving to make company a great place to work, and a company respected for the quality of its people and products. 
  • Action  as a role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs. 

Education: 

  • Associates degree in a related discipline and a minimum of 5 years industry experience or bachelor' s degree in Life Sciences discipline and a minimum of 2-4  years' experience. 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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