Microbiologist Lead
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Apply Now Application ends in 27d 2h 13min
Job Detail
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Offered Salary 0
Job Description
Key Responsibilities:
- Responsible to establish and maintain microbial controls program ensuring that overall quality standards around microbial risks and controls are met.
- Lead, facilitate, write and/or approve on risk assessments for microbial controls and contamination investigations.
- Write the Contamination Control Strategy for the facilities and ensure periodic review
- Lead cross-functional teams through complex issues and challenges.
- Provide coaching and mentoring to contamination investigation teams.
- Ensure well written contamination investigation reports.
- Partner with training team and / or relevant SMEs to develop and deliver training solutions and build capabilities at site associated to microbial risk and controls, as well as clean room behaviors and aseptic techniques
- Participate in Quality Council and holistically assess and report, with cross-functional team, microbial trends from the various quality systems.
- Critically analyze data to recommend opportunities for robustness improvements.
- Implement endorsed projects to drive to desired future state (where applicable use of quality system workflows change control, CAPA, Quality Improvement Plan may be employed).
- Support new product transfers as the microbial contamination control expert.
- Support new product/new process/new equipment design for microbial control and support microbial risk assessments for new products and processes
- Support Quality Control team as needed to develop EM program and testing.
- Support Facility and Operations as needed to develop Cleaning and Disinfection program.
- Supports Operations as needed to develop Gowning and Qualification program including aseptic techniques.
Why You?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BS/BA degree including 8+ years OR MS or Ph.D degree including 5+ years of sterile pharma, biopharmaceutical or biologics industry-based experience
- Experience with Process Microbiology (risk assessment), Contamination Control, Sterility Assurance systems, Quality Control Microbiology or Quality Assurance or Operational Quality or MSAT
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Excellent technical writing skills and high attention to detail
- Knowledge in cGMP, CFR and other regulations in order to assure GMP compliance.
- Working knowledge of microbial risk assessments HACCP / FMEA is desirable
- Demonstrated knowledge of Quality by Design and risk management approaches
- Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
- Demonstrated self-starter with strong self-management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization.
- Strong organizational skills, data analysis, and strong computer skills.
- Good verbal and written communication ability and team oriented with strong interpersonal skills.
- Demonstrated self-starter with strong self-management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization.
Apply Now
Application ends in 27d 2h 13min