QC Microbiologist II

Location: Bedford, MA

Position Scope:

Responsible for microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation.)

Strategic Focus Area:

Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge.

Specific Responsibilities:

  • Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples
  • Perform company’s purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements
  • Complete all required documentation according to SOP
  • Write validation protocols, perform validation and write validation reports
  • Update database for microbiological and validation data
  • Perform environmental monitoring investigations, out of specification investigations, nonconformity investigations and other investigations as assigned
  • Perform and write quarterly environmental monitoring, bioburden, and water trending 
  • Write annual environment monitoring and water reports 
  • Write media fill reports on a biannual basis 
  • Performs Internal Audit assignments
  • Other duties and projects as assigned

Job Complexity:

Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to complete routine assignments with minimal supervision. 

Supervisory Responsibilities:

None.

Experience, Knowledge, and Skills Required:

  • Requires BS in microbiology, biology or related science
  • 2+ years’ experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP, bacteriostasis and growth promotion assay
  • Ability to perform root cause analysis and write investigation reports
  • USP and EP requirements related to microbiological testing
  • Excellent verbal and written communication skills
  • Proven ability to meet deadlines for testing and reporting
  • Proficient in the use of Microsoft Office Suite 

Desired Experience, Knowledge, and Skills:

  • Experience with cGMP, GLP
  • Knowledge of FDA regulations, ISO requirements (9001, 13485 and 17025) and EU MDR
  • Experience in environmental monitoring of clean room, aseptic media fill evaluation
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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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