Om jobbet
The microbiology supervisor is responsible for overseeing the operations of the microbiology laboratory.
Duties include managing direct reports, acting as Subject Matter Expert (SME) and contributing to audit readiness.
Perform routine testing and per review as needed.
Role/Responsibilities:
- Management of lab staff direct reports including completion of performance feedback, reviews,
disciplinary action and time card administration
Ensure testing is initiated and performed in a timely manner and adhering to quality standards - Act as laboratory SME
- Draft protocols and coordinate with laboratory manager to conduct investigations and special
studies as needed - Draft and edit SOPs as needed
- Approve CoAs as needed
- Conduct and/or approve method suitability as needed
Adhere to SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA
regulations. - Perform microbiological testing and method validation related for the following microbiological test
methods:
o Sterility Testing per USP <71>
o Endotoxin per USP <85>
o Particulate Matter per USP <788>, <789>, <787>
o Water for Pharmaceutical Purpose <1231>
o Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>
o Other tests as needed - Microbiological growth promotion
- Adhere to controlled substance requirements
- Receive, and release media, buffers, and microorganism cultures
- Update and review microbiological trendin
- Compose, update, and review procedures and training materials
- Sanitize the laboratory incubators and refrigerator
- Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work
- Clean and sanitize the microbiology laboratory rooms surfaces and equipment
- Manage personal time off by requesting the time off in company time keeping system for either
- PTO or VPTO according to company policy for salary employees as well as approving requestsfor direct reports. See company handbook for policy details.
- Other duties as assigned
Din profil
Basic Qualifications
- Bachelor's degree (preferably in Chemistry or Biology) with 5+ years of experience in the pharmaceutical industry or at least 12 years of related experience, if no bachelor's degree
- Experience include 5+ years (or 12+ years, if no degree) of progressive laboratory responsibility in support of pharmaceutical manufacturing or equivalent, related industrial or clinical experience
- 1-2 years’ experience in a supervisory, team lead/project lead capacity.
- Knowledgeable of quality control testing methods, validation techniques and concepts of microbiology
- Pass aseptic gowning and sterility testing qualifications.
- Pass vision requirements for visual inspection
- Understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications.
- Advanced communication, interpersonal, planning, and organizational skills
- Strong analytical and problem-solving skills, the ability to understand internal and applicable policies, procedures and standards.
Vi tilbyder
Our Benefits
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
- Competitive Salary
- Health, Vision, and Dental Insurance
- Company Paid Life Insurance
- Generous Paid Holidays
- Paid Volunteer Time
- Generous Paid Time Off and Rollover
- Company matching 401K and Retirement Savings Plans
- Employee Assistance Program
- Flexible working arrangements
Now let's not forget our site!
The FSS Boston facility is located in beautiful Canton, Massachusetts. Employees enjoy ample parking at a state-of-the-art compounding facility.
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.