Description:
Note:
First shift. May require some OT and weekend work
Main qualifications:
Bachelors Degree (in microbiology or related)
1yr Exp. (pharma)
Water Sampling and Testing
CGMP
word/excel proficiency
Position Summary:
This position performs microbial limits testing of water and environmental air monitoring (EM) samples, primarily from the Elizabeth and Edison facilities, at the Elizabeth Microbiology Laboratory. Performs quantitative microbial analyses on water and EM samples to ensure compliance with microbiological specifications and Alert/Action Limits, company standards, and governmental regulatory requirements. Uses approved test methods, protocols, procedures (SOPs) and corporate policies while maintaining adherence to current industry standards. Perform water and environmental monitoring (air) sampling. May be involved or responsible for performing micro-related Laboratory Investigations, audit/review of Micro Lab data, implementing CAPA, planning and scheduling of micro testing activities.
Essential Duties / Functions
Follows established laboratory safety procedures.
Receives Elizabeth / Edison water and EM samples.
Uses basic technical principles, theories, and concepts to conduct various microbiological laboratory activities, including water sample testing, environmental monitoring (EM) sample testing, growth promotion testing, and suspension preparation.
Analyzes environmental air monitoring (EM) and water samples, primarily for the Teva Elizabeth and Edison sites, while following current methods and procedures (SOPs).
Initiates and conducts microbiology laboratory investigations.
Sends samples to a third party microbiological laboratory for identification, as needed.
Maintains routine communications with the other QC Microbiologist located at the Elizabeth site regarding test results and any related Micro Lab Investigation Reports (LIRs), as applicable.
Documents all activities in a legible manner following established formats and procedures in compliance with Good Documentation Practices and cGMPs.
Identifies and troubleshoots problems with equipment and microbiological preparations.
Reviews microbiological data.
Handles microbial waste.
Performs other duties as assigned or as business needs require, such as ordering media, reagents and supplies for the microbial testing being performed in the Elizabeth Microbiology Laboratory.
Qualification and Requirements:
Requirements:
Education Required:
BS/BA in Biology / Microbiology / Biochemistry, or BS in a Related Science
Experience Required:
Minimum 1 year in a pharmaceutical laboratory environment.
Specialized or Technical Knowledge, Licenses, Certifications Required:
Must possess strong technical knowledge regarding various micro tests, including but not limited to, water and environmental air monitoring testing
Knowledge of microorganisms
Working knowledge of aseptic technique
Knowledge of cGMPs and Good Documentation Practices
Knowledge of compendia procedures and general chapters, where applicable (i.e., USP, NF, etc.).
Possess good written and oral communication skills
Proficiency with LIMS and Microsoft Office Word and Excel.
Possess strong mathematical skills fractions, percentages, ratios, and algebraic expressions.
Possess very good problem solving skills
Able to perform assigned tasks with minimal supervision
Physical Demand Requirement: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Approximately 60% standing or walking. Not allergic to chemicals found in the lab or production facilities.
Employment Type: Contractor
