Quality Control Associate, Microbiology

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  Medical Insurance

  
  


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  Dental Insurance

  
  


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  Vision Insurance

  
  


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  Company Paid Life Insurance 1X annual Salary

  
  


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  Voluntary Life Insurance

  
  


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  Long-Term Disability Insurance and Short-Term Disability Insurance

  
  


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  Flexible Spending Account and Health Saving Account

  
  


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  401(K) Retirement Plan

  
  


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  10 Days of Paid Time Off

  
  


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  10 Paid Holidays Annually

  
  

Position and Scope

The purpose of this position is to assist in establishing and managing a microbiology program that oversees aseptic fill/finish activities, environmental monitoring, gowning qualification, and the establishment of compendial microbiology assays that include endotoxin, bioburden, and sterility. The position is responsible for ensuring all activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and controls and drug product process validation is highly desired.

This role is 100% On-Site, Monday – Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:00am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

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  Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits

  
  


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  Supports assay transfer, qualification, and validation activities for microbial based assays or clients' specific methods

  
  


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  Author, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reports

  
  


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  Perform analysis on in-process samples, APIs, raw materials, and stability samples using existing methods

  
  


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  Perform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.

  
  


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  Initiate and participate in the investigation of environmental monitoring excursions and assesses potential impact on product quality

  
  


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  Support a Gowning Qualification Program for all manufacturing and QC personnel

  
  


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  Perform routine monitoring of pharmaceutical water and gas systems

  
  


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  Perform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testing

  
  


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  Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities

  
  


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  Assist in trending EM data and generate quarterly and yearly reports

  
  


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  Participate in inspection readiness activities

  
  


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  Interact closely with other departments to ensure efficient, compliant, and timely execution of project activities

  
  


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  Provide assistance as needed to maintain a functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties

  
  


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  Assist in investigation and review of GMP quality events, including but not limited to deviations, non-conformances, and audit findings

  
  


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  Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a client driven focus

  
  


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  Safely operate laboratory equipment in accordance to established practices and SOPs

  
  


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  Assist in training of additional team members

  
  


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  Under minimum supervision, support special projects as needed

  
  


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  Operates to the highest ethical and moral standards.

  
  


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  Adheres to quality standards set by regulations and Argonaut Manufacturing Services policies and procedures

  
  


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  Communicates effectively with supervisors, staff, and clients

  
  


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  Participate in projects within a team and as an individual

  
  


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  Support continuous improvement projects related to QC

  
  


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  Multi-task, prioritize workload, document properly and interpret data accurately

  
  


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  Follow laboratory safety requirements to promote a safety-first culture

  
  

Requirements and Qualifications

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  Combination of Undergraduate courses and on-the-job experience in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences)

  
  


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  Minimum three (3) years' experience in Quality Control and environmental monitoring of GMP facilities

  
  

• High intelligence and problem-solving skills


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  Excellent oral and written communication and listening skills

  
  


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  High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction

  
  


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  Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred

  
  


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  General knowledge of one or more of compendial methods such as: Bioburden, Endotoxin, Growth Promotion, Sterility, and other microbiological methods

  
  


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  Knowledge in environmental excursion investigations, root cause analysis, out of specifications, and knowledge of cleanroom practices is preferred

  
  


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  Direct experience with endotoxin, bioburden, and growth promotion methodologies. Experience in sterility testing is highly desired.

  
  


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  Experience with transfers and qualification/validations of large molecule focused analytical methods

  
  


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  Must have experience with Microsoft Office applications

  
  


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  Experience with quality software and 21 CFR 11 applications preferred