Microbiology Analyst

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Job Description Summary
The Quality Control (QC) Microbiology Analyst is responsible for QC Microbiology testing within the QC laboratory and CPMF Manufacturing Area to support the College Park Manufacturing Facility. The role will ensure adherence with regulatory and best practice requirements while delivering consistently for the internal and external customers.

Job Description

Essential Functions

• Work within the QC Microbiology laboratory to ensure consistent delivery to customers
• Ability to perform key tasks such as:
  • Environmental Monitoring
  • Water Sampling
  • Water Testing
  • Total Organic Carbon Testing
  • Conductivity Testing
  • Bioburden Testing
  • Endotoxin Testing
  • Compendial Verifications
  • Method Transfer
  • Validations
  • Growth Promotion Testing
  • In-process testing
  • Data analysis and trending
• Perform testing and ensure that the testing schedule is adhered to and the results reported in a timely manner, escalation of any issues LIR/OOS/OOT/etc.
• Liaise with other functions on site to facilitate testing to ensure schedule adherence.
• Oversight of contract testing laboratories associated with Microbiological Testing– shipping, reconciliation and trending of test results
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Participate in the Compendial verification, validation and transfer of Microbiological Testing in house.
• Prepare for and support internal and external audits (e.g. HPRA, FDA, Corporate etc.).
• Lead and implement initiatives that add value to QC Microbiology and site operations.

Qualifications / Minimum Requirements

• Minimum BSc in Science or equivalent level (level 7 Laboratory apprentice qualification)
• Minimum 2 years' experience in a similar role
• Must include role(s) within a QC setting
• Solid experience of Bioburden, Endotoxin and Environmental Monitoring preferred
• Experience with method validation/method development preferable
• Pharmaceutical drug/process development experience preferable
• Self-starter with strong work ethic
• Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• Must be able to function effectively in a teamwork environment
• Ability to identify, execute and prioritize work tasks/projects and know when to escalate
• Excellent problem-solving, decision-making and communication skills
• Good computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint)
• Ability to plan, organize, and prioritize effectively
• Good technical and compliance-based writing skills
• High levels of integrity and trustworthiness

Organizational Relationship / Scope

Reporting to the QC & Microbiology Lead the QC Microbiology Analyst is required to perform testing and analysis within QC Microbiology. The QC Microbiology Analyst works closely with Senior QC Microbiology Analyst and QC Microbiology Analysts within the lab and cross functionally with including but not limited to QC, QA, Validation, Engineering and Manufacturing across College Park. The QC Microbiology Analyst is also required to liaise with and work with the wider Global Quality function.

Working Conditions

• This is a lab-based role.
• Working hours flexibility required.
• Availability to work weekends required.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing

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