Über die Tätigkeit
The Microbiology Supervisor is responsible for effectively hiring, developing, coaching, counselling, managing, and motivating staff. Responsible for executing and supervising the activities of AQL Tech I through Microbiology Specialist levels. Responsible for the timely and accurate completion of required microbiological testing of raw materials, in-process and finished products as well as personnel and production monitoring. Assures compliance to GMP and product specifications along with Fagron procedures. Identifies areas for validation and/or improvement and develops protocols, as needed. Keeps Manager of Quality Control informed of all departmental activities and product related events
- Executes, supervises, and schedules daily activities of QC Microbiology and AQL personnel
- Oversees the training of department personnel. Conducts performance evaluations Effectively delegates to assure job objectives are met on a timely basis
- Assures execution of monitoring and testing programs to assess the microbiology quality parameters of raw materials, components, in-process and finished goods, environmental systems and effectiveness of production processes
- Reviews GMP and procedural issues identified and resulting training activities.
- Establishes goals for the timely release of product and performance of projects Monitors performance of the group against the goals to identify and implement needed corrective action
- Ensures that a component, raw material, product or an environmental system not meeting specifications is promptly investigated. Identifies possible root cause, corrective action needed and evaluates the impact upon the lot Supervises or conducts investigations of non-conforming/Hold product or components
- Generates, reviews, and updates Standard Operating Procedures. Ensures timely reviews of existing SOPs are assigned and completed
- Maintains current knowledge of cGMPs and regulatory issues/guidelines. Reviews GMP and procedural issues identified and resulting training activities
- Assures department is equipped with functional, calibrated equipment and supplies
- Identifies significant adverse quality trends by preparing and analyzing summary reports and key process indicators Addresses quality control test results, microbial profiles of environmental areas, and customer complaints
- Ensures the accurate administration of SPC programs for the facility
- Supervises the collection and evaluation of documentation error data and reinspection data and ensures the necessary corrective actions are identified and implemented Reviews and evaluates monthly reports. Supervises and collects and evaluates monthly and annual reports, not limited to error, reinspection, or microbiological data Executing necessary corrective actions
- Ensures adequate evaluation of inspection and packaging defects and reinspection trends
- Supervises the coordination and investigation of the product complaint system for microbiological components
- Reviews and evaluates investigational reports, corrective actions and monthly/annual reports for products and or microbiological data
- Supervises the collection and evaluation of incident reports and change control data and ensures the necessary corrective actions are identified and implemented
- Supervises the administration of the department self-assessment program. Ensures the timely completion of each assessment reviews and evaluates the observations and ensures adequate follow up is performed
- Schedules personnel to perform/assist with vendor visits and audits as needed or requested
- Oversees microbiology department training of non-departmental personnel in aseptic technique and related topics Supervises gowning and aseptic technique qualification/requalification program for employees
Ihr 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 must 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.
- Must be knowledgeable of quality control testing methods, validation techniques and concepts of microbiology.
- Must be able to pass aseptic gowning and sterility testing qualifications.
- Must be able to pass vision requirements for visual inspection.
- Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications.
- Proficient in Microsoft Office applications including Word, Excel, and PowerPoint.
- Advanced communication, interpersonal, planning, and organizational skills are essential.
- Strong analytical and problem-solving skills, including the ability to understand internal and applicable policies, procedures and standards.
- Demonstrated ability to work independently as well as in a team environment.
- Must be a self-starter, an independent thinker and a rapid decision maker.
- Ability to work effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
Unser Angebot
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.