Description
Job Title: QC Microbiologist
Location: Hampshire (Laboratory-based)
Hours: Early Shift (Monday to Friday, 5:45 AM - 2:00 PM)
Overview
The QC Microbiologist plays a key role in ensuring product quality and safety by performing microbiological testing on DI water, raw materials, bulk, and finished products, as well as conducting environmental monitoring. This position involves releasing products that meet Quality Control (QC) standards and supporting QC Analytical Chemists in testing tasks as needed. The role is strictly laboratory-based, requiring adherence to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Health and Safety regulations. Accurate record-keeping in laboratory books, master documents, and databases is essential.
Key Responsibilities
Upon completion of training, the primary responsibilities will include:
- Microbiological Testing: Conduct microbiological analysis of DI water, raw materials, bulk, and finished products, following established Standard Operating Procedures (SOPs) and Laboratory Methods.
- Environmental Monitoring: Perform environmental testing according to SOPs and Laboratory Methods to ensure compliance.
- Product Release: Authorize the release of raw materials, bulk, and finished goods from quarantine once QC testing is complete and standards are met.
- Validation: Assist in validating cleaning procedures, test methods, and other processes as required.
- Physical Testing: Support the QC Analytical Chemist by conducting physical tests on bulk and finished products, adhering to SOPs and Laboratory Methods.
- Sample Management: Ensure all samples are properly controlled and retained according to SOPs.
- Non-Conformance Reporting: Identify and report any non-conforming raw materials, bulks, or finished products following SOP guidelines.
- Laboratory Standards: Help manage and maintain laboratory standards as per customer or regulatory requirements.
- Database Maintenance: Maintain accurate records in databases for all tests performed.
- Issue Resolution: Assist in resolving technical and quality-related issues.
- Equipment Operation: Operate and maintain laboratory equipment, ensuring proper functionality. Report any equipment issues to the QC Laboratory Supervisor.
- General Duties: Maintain high standards of GLP and GMP in the lab and perform other duties as assigned by the QC Laboratory Supervisor or Quality Manager.
Required Skills & Experience
- Education: Degree in a science-related field, preferably Biology or Microbiology – essential.
- Microbiological Testing Expertise: Solid understanding of microbiological testing techniques through hands-on experience – essential.
- Environmental Testing: Knowledge of environmental testing practices – desired.
- Validation Experience: Familiarity with validation processes for test methods, cleaning procedures, and production – desired.
- Physical and Chemical Testing: Experience in physical and chemical testing techniques – desired.
- Regulatory Compliance: Prior experience working in a GLP and GMP-regulated environment – desired.
Key Competencies
- Teamwork: Ability to work effectively both independently and as a flexible member of a small team.
- Organization: Strong organizational skills with the ability to manage workload and take initiative.
- Attention to Detail: High accuracy in work and meticulous attention to detail.
- Adaptability: Willingness to adapt to changing priorities and workloads.
- IT Skills: Proficient in using computerized information systems to manage data; moderate skills in Microsoft Word, Excel, Outlook, and PowerPoint are essential.
Additional Information
- Maintenance Duties: Ensure proper cleaning and maintenance of laboratory equipment, glassware, and instruments.
- Safety Compliance: Follow all health and safety guidelines to maintain a secure working environment.
- Reporting: Accurately record and report data according to GLP and GMP standards.
This role requires a dedicated individual with a strong scientific background, excellent analytical skills, and a keen eye for detail to ensure that all products meet stringent quality standards.
