Project Description: This position leads environmental/microbiological related investigations, prepares quarterly/ annual water system trend reports, monitors and trends the environmental monitoring program, and collaborates with other departments to ensure all sampling (water, EM, swabbing, raw materials) is performed according to schedules and shipped to external testing laboratories, as appropriate.
Ensures compliance with microbiological specifications and Alert/Action Limits, company standards, and governmental regulatory requirements.
May be involved or responsible for performing micro-related Laboratory Investigations, audit/review of Micro Lab data, implementing CAPA, and planning and scheduling of micro testing activities.
May also perform quantitative microbial analyses on water and EM samples in the company Fairfield Microbiology Laboratory to ensure compliance with microbiological specifications and Alert/ Action Limits, company standards, and governmental regulatory requirements, as needed.
Follows established laboratory safety procedures.
Collaborates with other Elizabeth and Edison site departments to ensure all microbiological sampling (water, EM, swabbing, raw materials, etc.) is performed according to schedules.
Ships samples to external microbiology testing labs, as required.
Ensures EM media is qualified and approved for use.
Performs Environmental Monitoring (sampling) of the ELZ and EDN facilities.
Monitors receipt of test results from external testing facilities for all sample types.
Performs microbiology laboratory investigations, if required.
Evaluates microbial identification/characterization of laboratory isolates (gram stain, presumptive tests, rapid ID kits, etc.), if required.
Documents all activities in a legible manner following established formats and procedures.
Performs data trending and assessment of results.
Identifies and troubleshoots issues with microbiological data/results and recommends solutions.
Writes, revises, and reviews microbiology-related SOPs and protocols.
Evaluates/audits and reviews generated Microbiology Laboratory data.
When needed as a backup for the QC Microbiologist(s) working at the Fairfield Microbiology Laboratory performing testing of the Elizabeth and 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 company Elizabeth and Edison sites, while following current methods and procedures (SOPs).
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 Fairfield Microbiology Laboratory.
Required Skills: BS/BA in Biology / Microbiology / Biochemistry, or BS in a Related Science
Minimum of 3 years' experience in a Microbiology testing laboratory.
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 .
Ability to work in office and laboratory environments.
Approximately 60% standing or walking.
The employee is occasionally required to sit, climb, or balance, and stoop, kneel, crouch or crawl.
Ability to wear/use personal protective equipment (such as a lab coat, goggles, masks, etc.), as required.
Ability to 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.
Not allergic to cephalosporins or chemicals found in the lab or production facilities.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Angie: email@example.com
ALPHA'S REQUIREMENT #22-02603
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE