One of the world’s leading contractors in the Industrial & Household, Cosmetics and Pharmaceuticals fields. The company offers customers impeccable service by providing tailored R&D, production and packaging facilities which fully satisfy their needs.
JOB SUMMARY:
Performs microbiological assays of raw materials, production intermediates and bulk samples, finished products, water testing, comprised air testing, environmental monitoring samples, and process & cleaning validation samples, and packaged samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, and standard operating procedures. Results are compared with specifications and documented. Incumbent has working knowledge of fundamental technical and quality concepts and receives minimal supervision on routine assignments.
RESPONSIBILITIES:
- Performs microbiological assays of raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, and packaged samples.
- Prepare Media following SOP’s, perform growth promotion to qualify each batch of Media before release for use in testing.
- Perform gram staining, identifying type of bacteria per USP methods.
- Ensure that all test methods follow up to date USP methods and customer requirements.
- Communicate any OOS’s for Micro immediately to Manager and Director of quality. Notify operations if there is any impact to bulk or packaging and stop the use of the bulk or the packaging operations until OOS is investigated and confirmed.
- Participle in Micro failure investigations as member of cross functional team
- Update/author SOP’s as needed
- Perform trending analysis on water, environmental and comprised air to ensure that systems are in state of control
- Perform periodic testing of OTC products placed on real time stability studies per stability protocol SOP.
- Support regulatory, internal and customer audits as needed.
- Manage Lab Micro lab supplies ensuring that supplies are ordered on time to prevent any disruptions to the day to day activity.
- Create new test methods based on customer and product suitability requirements.
Analyzes results
- Accountable for the accuracy and validity of test results. Performs mathematical calculations, interprets results, records observations, and performs peer review. Identifies basic technical issues, atypical or out-of-specification test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct. Uses electronic documentation systems to collect and manage data. Uses SOPs and problem solving skills to complete assignments.
Lab Support
- Schedules daily assignments under the direction of the Quality lab manager and ensures appropriate workflow for testing and peer review activities of their lab. Maintains all related records, prepares and records media, buffers, and reagents, etc., and maintains work area in a neat and orderly manner.
SOPs and Administrative
- Learns to analyze and interpret project/study/investigation results and findings. Determines next steps under guidance of management and senior peers in compliance with SOPs and applicable regulations, carries out technical and administrative duties as assigned.
REQUIREMENTS:
- BS degree required in Biology, Microbiology, Biochemistry or relevant science discipline;5-10 years of relevant Quality experience preferably in the bio/pharmaceutical industry.
- MS degree preferred in Biology, Microbiology, Biochemistry or relevant science discipline; 3-5 year of relevant quality experience preferably in the bio/pharmaceutical industry.
- Experience in FDA regulations and USP Micro test methods.
Skills and abilities:
- Requires basic knowledge of fundamental quality concepts. Learns and performs defined procedures.
- Working knowledge and practical application of relevant techniques and instrumentation such as: asceptic technique, sterilization procedures, inoculation, isolation, gram staining, etc.
- Ability to interpret and document test results according to standard operating procedures and using cGMPs;.
- Learns to identify technical problems and solve these under the guidance of management.
- Receives minimal supervision on routine work, and specific direction on new work. Organizes daily activities, including technical aspects, to ensure timely completion of assignments.
- Ability to participate on teams comprised of immediate group members or to work cross functionally, if necessary.