Aegis Worldwide
Senior Microbiology Manager
1st Shift/$120-$145k/Full-Time
Fishers, IN
Overview:
Aegis Worldwide is curently partnered with one of the world's largest nuclear medicine company, specializing in the development, manufacturing, and distribution of radiopharmaceuticals. Their products are used in both diagnostic imaging (like SPECT and PET scans) and cancer therapy.
Requirements:
- Bachelor Degree in scientific discipline required or equivalent work experience.
- 12 - 15 or more years Quality Control relevant leadership experience, with two or more years of experience in a management role; (preferably managing a team of ten or more multi-shift employees).
- Strong knowledge of cGMP requirements.
- Strong knowledge of laboratory equipment/product validation
- Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.
Responsibilites:
- Manage Quality Control laboratories: Microbiology/Environmental Monitoring.
- Ensure all necessary testing is carried out.
- Approve specifications, sampling instructions, test methods, procedures and other QC procedures.
- Approve and monitor any contract testing laboratory for compliance and test results.
- Ensure appropriate validations/qualifications are completed and approved.
- Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.
- Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.
- Coach and develop the team to team ownership.
- Ensure team compliance with all policies, procedures and site/company regulations.
If interested in this opportunity, we are currently scheduling interviews, apply now and we can get you scheduled.