Anu Michael Email & Phone Number

Spring, Tx, Us

The Woodlands, Texas, Us

Blue Bell, Pennsylvania, Us

• Develop and execute EMPQ for GMP cleanrooms for the client.• Develop new EM Program for the client. • Develop new Alert and Action EM limits for the facility. • Develop new EM training program including ILTs and OJTs for the QC department. • Develop numerous SOPs, WIs, and Forms for the QC department. • Assist and participate in EM and facility related investigations. • Generate quarterly and annual EM trend reports for the facility. • Determine environmental isolates for the facility. • Prepare the QC department to run EMRBs monthly. • Develop an excel trending tool for the environmental monitoring training program. • Develop growth promotion and culture verification procedures for the site. • Develop baseline EM protocol for CNC manufacturing area. • Develop a new aseptic gowning qualification program for the site. • Develop a new plate count procedure for the site.• Serve as an SME for EM related processes and projects. • Train new QC analysts on EM related procedures.• Perform gap analysis on cleaning validation studies.

Somerset, Nj, Us

● Oversee the Environmental Monitoring program for ISO/EU classified cleanrooms, including the scheduling of activities for QC Microbiology personnel and assessing data trends. ● Responsible for testing of starting materials, in process and release samples for on-time lot disposition utilizing technical expertise in USP/EP/JP compendial tests, such as Sterility, Bacterial Endotoxin, Microbial Enumeration and Biological Indicators.● Lead complex investigations related to contamination control of the facility, including assigning appropriate CAPA.● Develop associated policies and procedures for the Microbiology laboratories operations, interfacing with investigators during both internal and external inspections.● Participate in regulatory and client audits. Evaluate audit observations and develop responses. and oversight for related action plans, making critical decisions concerning testing operations.● Generate cost savings and provide new product support.● Manage operations for the QC Microbiology laboratories and supporting the QC documentation and LIMS activities.● Serve as a functional representative on project teams.● Oversee development of new QC Microbiology laboratory and EMPQ of new GMP facilities. ● Generate monthly/quarterly metrics for KPIs, process improvements, etc. for quarterly leadership meetings.

Somerset, Nj, Us

● Generates new/revised Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures.● Participates in the review of work performed by department staff for accuracy, completeness and conformance to GDP and product specifications.● Manage inventory of media, supplies, and microorganisms for the lab by working closely with the vendors.● Serve as an alternate for all analysts in the lab to provide immediate assistance in completing urgent tasks.● Generate and summarize quarterly and annual trend reports for environmental monitoring results.● Assists in the hiring and training of EM team members.● Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.● Mentors and develops new team members including training in Standard Operating Procedures and On The Job Training (OJT).● Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports.

Somerset, Nj, Us

-Manages shift activities of QC Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis.-Assists in the hiring and training of EM team members. Assures that steps are taken to maintain positive morale.-Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.-Generates new/revises Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures.-Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.-Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.-Participates in the review of work performed by department staff for accuracy, completeness and conformance to GDP and product specifications.-Mentors and develops new team members including training in Standard Operating Procedures and On The Job Training (OJT).-Assures department is equipped with functional, calibrated equipment and necessary supplies.Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports.-Developed and deployed new EM excursion investigation process.-Collaborate with outside vendors to create an efficient inventory and purchasing management system.-Collaborate with other departments to address process improvements.-Assumes other duties and responsibilities as assigned.

Hunt Valley, Maryland, Us

Hunt Valley, Maryland, Us

• Perform environmental monitoring in aseptic and oral dosage manufacturing areas• Prepare and perform growth promotion and sterility tests on media• Perform Bacterial Endotoxin test using Gel-Clot method• Record and analyze raw data • Generate data reports and trends• Perform Hold-time studies on need basis • Sampling and testing of Water Systems• Read, understand and follow SOP's and comply with GMP's Revise and write SOPs and Forms to make it more time efficient• Perform Nitrate testing of water samples• Perform Microbial Limit and Bioburden Tests on raw material samples, finished products and stability products• Perform validation support activities such as testing for biological indicators for terminally sterilized products• Support and participate in completing investigation reports. • Perform Viability test and qualify Biological Indicators in-house. • Train and qualify fellow microbiologists to perform tests and environmental monitoring. • Perform particulate matter tests.

Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)Builds credibility within the lab group by performing high quality workWorks closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaignsPerforms media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrityActs as Quality Control authority for aseptic flow and behavior within cleanroomsUtilizes Excel to enter, compile, and trend environmental data for reporting purposesWorks closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facilityEffectively communicates results of own work through discussions and documentation with some input from supervisorOther duties as assigned

Hunt Valley, Maryland, Us

• Perform environmental monitoring in aseptic and oral dosage manufacturing areas• Prepare and perform growth promotion and sterility tests on media• Record and analyze raw data • Generate data reports and trends• Sampling and testing of Water Systems• Read, understand and follow SOP's and comply with GMP's• Perform Nitrate testing of WFI water samples• Perform Microbial Limit Tests on raw material samples• Perform validation support activities such as testing for biological indicators for terminally sterilized products

Philadelphia, Pennsylvania, Us

• Provide prompt service in the Pharmacy Department• Perform computer entry of prescription information including but not limited to: patient search, prescriber search, drug selection, prescription interpretation & entry, insurance billing and basic problem resolution.• Provide customer assistance and advice regarding their prescriptions • Protect patient data through HIPAA policies

Master Of Science (M.S.), Health Informatics Administration

Bachelor Of Science (B.S.), Biology/Biological Sciences, General

Biology/Biological Sciences, General