Sr Associate QC - Microbiology

Specific Job Duties:

• Perform Sterility testing as a main priority with efficiency and accuracy
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
•  Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Approve lab results
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams
• May interact with outside resources

Basic Qualifications

• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Qualifications

• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
• Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Skills

• Take initiative to identify and drive improvements
• Excellent verbal and written communication skills
  •  Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
  • Presentation skills
  • Escalate issues professionally and on a timely basis
• Decision Making skills
• Teamwork and Coaching others
• Negotiation and Influence skills
• Problem solving skills
  • Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
  • Ensures compliance within regulatory environment
  • Develops solutions to technical problems of moderate complexity
  • Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
  • Interprets generally defined practices and methods
  • Able to use statistical analysis tools to perform data trending and evaluation

• Project Management and organizational skills, including ability to follow assignments through to completion
  

Competencies

• Technically strong background in microbiology and aseptic manufacturing
• Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage
• Experience with Regulatory inspectors and interacting with inspectors desirable
• Demonstrated ability to work independently and deliver right first time results
  • Works under minimal direction
  • Work is guided by objectives of the department or assignment
  • Follows procedures
• Refers to technical standards, principles, theories and precedents as needed
• May set project timeframes and priorities based on project objectives and ongoing assignments.
• Recognizes and escalates problems
  • Demonstrated leadership and communication skills
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies

    Specific Job Duties:

  • Perform analytical testing as a main priority with efficiency and accuracy
  • With a high degree of technical flexibility, work across diverse areas within the lab
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Report, evaluate, back-up/archive, trend and approve analytical data.
  • Troubleshoot, solve problems and communicate with stakeholders.
  • Initiate and/or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Write protocols and perform assay validation and equipment qualification/verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  •  Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
  • Approve lab results
  • May participate in lab investigations.
  • May provide technical guidance.
  • May train others.
  • May contribute to regulatory filings.
  • May represent the department/organization on various teams
  • May interact with outside resources

  • Basic Qualifications

  • Bachelors degree in a science discipline
  • Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

  • Preferred Qualifications

  • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
  • Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

  • Skills

  • Take initiative to identify and drive improvements
  • Excellent verbal and written communication skills
    •  Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
    • Presentation skills
    • Escalate issues professionally and on a timely basis
  • Decision Making skills
  • Teamwork and Coaching others
  • Negotiation and Influence skills
  • Problem solving skills
    • Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
    • Ensures compliance within regulatory environment
    • Develops solutions to technical problems of moderate complexity
    • Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
    • Interprets generally defined practices and methods
    • Able to use statistical analysis tools to perform data trending and evaluation
  • Project Management and organizational skills, including ability to follow assignments through to completion
    

  • Competencies

  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage
  • Experience with Regulatory inspectors and interacting with inspectors desirable
  • Demonstrated ability to work independently and deliver right first time results
    • Works under minimal direction
    • Work is guided by objectives of the department or assignment
    • Follows procedures
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments.
  • Recognizes and escalates problems
    • Demonstrated leadership and communication skills
    • Auditing documentation and operation process
    • Demonstrated ability to interact with regulatory agencies