Senior Specialist, Quality Control (Microbiology)

Welcome to Amgen, where we strive to improve lives and bring innovative medicines to patients worldwide. We are seeking a highly skilled and experienced Senior Specialist in Quality Control with a focus on Microbiology to join our dynamic team.As a Senior Specialist, you will play a critical role in ensuring the quality and integrity of our products through the implementation and maintenance of microbiological testing methods and procedures. You will work closely with cross-functional teams to support product development, manufacturing, and release activities while adhering to regulatory requirements and industry standards.We are looking for a passionate individual with a strong background in microbiology, quality control, and cGMPs. If you have excellent attention to detail, exceptional problem-solving skills, and a desire to make a meaningful impact in the pharmaceutical industry, we invite you to apply for this exciting opportunity.

1. Develop and maintain microbiological testing methods and procedures for Amgen's products in compliance with cGMPs and regulatory requirements.
2. Lead and coordinate microbiological testing activities, including sample preparation, testing, and data analysis.
3. Collaborate with cross-functional teams to support product development, manufacturing, and release activities.
4. Monitor and trend microbiological data to identify potential issues and implement corrective actions.
5. Review and approve microbiological testing results and documentation for accuracy, completeness, and compliance.
6. Conduct investigations and root cause analyses for out-of-specification results, non-conformances, and deviations.
7. Develop and implement strategies for continuous improvement in microbiological testing methods and procedures.
8. Ensure laboratory equipment and facilities are maintained and calibrated according to established procedures.
9. Train and mentor junior team members on microbiological testing methods, procedures, and cGMPs.
10. Stay informed about industry trends, regulations, and best practices related to microbiology and quality control.
11. Participate in audits and inspections by regulatory agencies and assist with responding to findings.
12. Communicate effectively with internal and external stakeholders, including presenting microbiological data and reports.
13. Identify and implement innovative technologies and processes to enhance microbiological testing capabilities.
14. Maintain accurate and up-to-date records and documentation of all microbiological testing activities.
15. Adhere to all safety and compliance protocols and promote a culture of safety within the department.

According to JobzMall, the average salary range for a Senior Specialist, Quality Control (Microbiology) in Holly Springs, NC, USA is between $70,000-$90,000 per year. This may vary depending on the specific company, industry, and level of experience of the individual. Additionally, factors such as education, certifications, and job responsibilities can also impact salary.

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.