Job Title: Associate Microbiology
About Our Company:
Join a leading pharmaceutical organization committed to delivering safe and effective products to patients worldwide. Our culture thrives on innovation, science-driven compliance, and a patient-first approach. Here, your work directly contributes to upholding the highest quality standards, adapting and evolving to meet global health needs. We are dedicated to ensuring that every product we deliver is of the highest standard, making a tangible difference in patient care.
The Opportunity:
We are seeking a dedicated and skilled Associate Microbiologist to contribute significantly to our Quality Control team. This pivotal role is instrumental in ensuring product quality through rigorous microbiological analysis and compliance with critical industry standards. You will leverage your expertise in a dynamic environment, playing a crucial part in maintaining our unwavering commitment to excellence and directly impacting patient well-being.
Key Responsibilities:
- Prepare and maintain media stocks, including sterilization of accessories by autoclave cycles.
- Manage receipt, storage, and handling of Bio ball cultures; assist in maintaining Master cultures and preparing Cryo vials.
- Perform diverse microbiological tests such as water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test, CCIT, and micro challenge studies.
- Ensure training records are updated and accurately filed, reflecting current testing capabilities.
- Conduct sampling and labeling of materials as per defined procedures and verify all equipment and instruments.
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
- Ensure all documentation and quality records comply with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Review and revise Standard Operating Procedures (SOPs), analytical methods, and related documents to maintain currency.
- Analyze finished products, raw materials, and components; perform data entry, review, and approval in computerized databases; generate EMS reports.
- Contribute to complex projects, manage time effectively to meet targets, and develop work plans within a team, exercising judgment under supervision.
Required Qualifications:
- Master’s degree in Microbiology or Biotechnology with 4-5 years of relevant experience in the pharmaceutical industry.
- Demonstrated technical skills in method validation and testing.
- Ability to read and understand applicable compendial methods, SOPs, technical procedures, and governmental regulations.
- Strong knowledge of Good Manufacturing Practices (GMP) and its application standards, processes, and policies.
- Excellent organizational skills and a strong ability to multi-task.
- Strong written and verbal communication skills.
- Proficiency with unique Quality Control instruments for accurate sample management, retains management, interpretation, and evaluation.
Preferred Attributes:
- Proven track record in leading continuous improvement projects.
- Strong knowledge of lean manufacturing principles, Six Sigma methodologies, and statistical analysis.
- Excellent problem-solving skills and meticulous attention to detail.
- Ability to manage multiple priorities and meet deadlines.
- Strong interpersonal skills and the ability to communicate effectively with colleagues at all levels.
- Adaptability and willingness to learn new techniques and procedures.
- Experience using common AI tools, including generative technologies, to support problem-solving and enhance productivity, coupled with an understanding of responsible AI practices.
Apply Now:
If you are passionate about quality control in pharmaceuticals and eager to make a tangible difference in patient health, we invite you to apply. Join our team and contribute to a legacy of excellence in pharmaceutical quality.
