What are the responsibilities and job description for the QC Microbiology Supervisor position at Guerbet?
At Guerbet, we build lasting relationships so that we enable people to live better.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.
Achieve, Cooperate, Care, and Innovate are the values that we share and practice.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.
WHAT WE'RE LOOKING FOR:
Under the direction of the QC Laboratory Manager, the QC Microbiology Supervisor is responsible for the day-to-day operations of the QC Microbiology Laboratory. These duties include working with key stakeholders towards the best outcomes for the organization. The Supervisor will plan, direct and supervise the administrative and technical activities of the QC Micro Lab. The Supervisor is responsible for evaluating material and product quality by performing various procedures in the Microbiology Laboratory and manufacturing facility. The QC Supervisor role must possess the skills to interact with formulation, filling, validation, engineering, and packaging personnel in support of those functions. The qualified candidate will work with, and guide the efforts of Microbiology Laboratory personnel to assure test results, procedures, and methods are written. The supervisor must have the ability to execute testing in a timely manner. The candidate must have the ability to work with a sense of urgency, assist with maintenance and analysis of Microbiological data, and work with other plant personnel to resolve problems related to actual or potential product quality problems. The Supervisor must have 7-10 years of hands on laboratory experience, and have the ability to work independently with minimal supervision. This position is located at our Raleigh, NC site.
YOUR ROLE:
Leads and executes protocols (including environmental monitoring studies and equipment/method validations).
Performs biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components.
Accountable for the accuracy and validity of testing results.
Analyzes trends microbiology data on a monthly basis to identify potential concerns with product quality and correct deviant situations.
Leads studies to support sterilization validation and validation of endotoxin removal.
Compiles data and generates reports in support of investigations, APQRs, KPI’s, QMRs, and validations.
The Supervisor will be responsible for laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, new product introduction, records review, SOP/SM-R/specification management, and auditing.
YOUR BACKGROUND:
Education
Bachelor's Degree preferably in Microbiology, Biology or similar life science
Experience
Minimum 7 years working in Microbiology, preferably in the pharmaceutical industry
Skills/Qualifications
Good interpersonal and verbal/written communication skills; able to use computer for data analysis
Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. Self-motivated, energetic, enthusiastic, and team oriented
Ability to train personnel on various procedures. MS Excel, PowerPoint, Access, and investigation writing. Effective communication with both team members and other plant support groups.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.
Achieve, Cooperate, Care, and Innovate are the values that we share and practice.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.
WHAT WE'RE LOOKING FOR:
Under the direction of the QC Laboratory Manager, the QC Microbiology Supervisor is responsible for the day-to-day operations of the QC Microbiology Laboratory. These duties include working with key stakeholders towards the best outcomes for the organization. The Supervisor will plan, direct and supervise the administrative and technical activities of the QC Micro Lab. The Supervisor is responsible for evaluating material and product quality by performing various procedures in the Microbiology Laboratory and manufacturing facility. The QC Supervisor role must possess the skills to interact with formulation, filling, validation, engineering, and packaging personnel in support of those functions. The qualified candidate will work with, and guide the efforts of Microbiology Laboratory personnel to assure test results, procedures, and methods are written. The supervisor must have the ability to execute testing in a timely manner. The candidate must have the ability to work with a sense of urgency, assist with maintenance and analysis of Microbiological data, and work with other plant personnel to resolve problems related to actual or potential product quality problems. The Supervisor must have 7-10 years of hands on laboratory experience, and have the ability to work independently with minimal supervision. This position is located at our Raleigh, NC site.
YOUR ROLE:
Leads and executes protocols (including environmental monitoring studies and equipment/method validations).
Performs biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components.
Accountable for the accuracy and validity of testing results.
Analyzes trends microbiology data on a monthly basis to identify potential concerns with product quality and correct deviant situations.
Leads studies to support sterilization validation and validation of endotoxin removal.
Compiles data and generates reports in support of investigations, APQRs, KPI’s, QMRs, and validations.
The Supervisor will be responsible for laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, new product introduction, records review, SOP/SM-R/specification management, and auditing.
YOUR BACKGROUND:
Education
Bachelor's Degree preferably in Microbiology, Biology or similar life science
Experience
Minimum 7 years working in Microbiology, preferably in the pharmaceutical industry
Skills/Qualifications
Good interpersonal and verbal/written communication skills; able to use computer for data analysis
Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. Self-motivated, energetic, enthusiastic, and team oriented
Ability to train personnel on various procedures. MS Excel, PowerPoint, Access, and investigation writing. Effective communication with both team members and other plant support groups.
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