The Sr. Microbiologist conducts diverse biological assays on raw materials, in-process samples, finished products, and environmental monitoring samples, following USP, FDA, and regulatory guidelines. Utilizes specialized techniques for qualitative, quantitative, and investigative analysis. Ensures compliance with client’s SOPs requirements. Compares results with specifications, documents findings, and collaborates with Microbiology lab personnel to uphold testing protocols.
Responsibilities
- The QC Sr. Microbiologist is the highest level of QC microbiology laboratory in Client and is expected to embrace a "team" working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed in the job description as allowed by the limitations of training, experience, and/or education.
- Leads diverse protocols, including environmental studies and validations, for microbiology testing services. Conducts biological assays, troubleshoots technical issues, and performs method validation with minimal guidance.
- Ensures scientific suitability of test methodologies, investigates, and resolves problems, and teaches gown qualifications within a team environment.
- Ensures testing result accuracy and validity, analyzing monthly microbiology data to identify and correct potential product quality concerns.
- Develops problem-solving skills, utilizing Laboratory Information Management Systems, and compiles data for reports related to investigations, APQRs, KPIs, QMRs, and validations.
- Maintains records, prepares materials, and keeps the work area organized. Coordinates testing activities and represents the microbiology department in process improvement teams.
- Supports inventory management and protocol execution, ensuring the laboratory meets audit requirements. Records results and performs special testing, instrument, and process validations.
- Takes an active role in laboratory QC functions, including OOS investigation, SOP management, validation activities, and auditing, contributing to maintaining an audit-ready status for global regulatory compliance.
- Trains and mentors more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor.
- Analyzes and interprets project/study/investigation results and findings.
- Review and approve QC test results as well as logbooks for accuracy and completeness and conformance to SOPs.
- May schedule laboratory testing and associated activities to minimize operational disruptions to departments.
- Performs calibration and maintenance of analytical instruments as required.
- Performs instrument/method troubleshooting within analytical method parameters.
- Writes, revises, reviews, and implements technical documentation including protocols, reports; reference standard qualification reports; analytical test procedures; and change controls. Conducts testing to evaluate planned changes to compendial (e.g. USP, JP, EP) test methods so that these methods can be implemented in accordance with the requirements.
- Reviews and/or writes technical reports, procedures, and protocols.
- Provides problem solving skills to support the resolution and documentation of investigations for laboratory and manufacturing issues.
- Assists with determination of root causes of non-conformances and recommends corrective actions.
- Draws conclusions from data and communicates those conclusions is writing.
- May perform internal audits of Quality Control.
- May perform external audits of vendors with respect to laboratory GMP’s.
Qualifications
Competencies:
Education / Experience:
- Minimum of seven years of experience in the Pharmaceutical or Biotechnology industry with a bachelor’s degree in microbiology, Biology or related scientific field required. Alternately, four to six years of experience with a master’s degree in microbiology, Biology, or related scientific field. Alternately, two to four years of experience with a PhD in microbiology, Biology, or related scientific field-Required.
- Experience with Microbiological Method validation/Method Verification-Required.
- Candidate must have broad knowledge in all types of microbiological compendia testing (USP, EP, JP, BP) -Required.
- Good written English and verbal communication skills-Required.
- Must be highly organized and able to work under pressure.
- Must have strong interpersonal and leadership skills.
- Must be computer literate with knowledge in all Microsoft business applications.
- Strong background in scientific software for identification system such as Vitex is a plus.
Judgment / Decision Making:
Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within the framework of departmental or functional guidelines, requiring interpretation and original thinking.
Work Environment:
A laboratory environment with exposure to microorganisms, safety cabinets, heat, and electrical current.
Physical Demands:
Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents. The majority of time is spent sitting and walking. Often required to lift objects weighing up to 20 pounds.
