QC Microbiology Analyst

The Staffing Resource Group, Inc
Harmans, Maryland, US
Jul 09, 2021
Aug 04, 2021
Employment Type
Full time
Salary Type
QC Microbiology Analyst I/IISRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: QC Microbiology Analyst I/IILocation: Harmans, MDIndustry: PharmaceuticalHours: SHIFT: Weekend Shift (F-M) 8AM-5PMSalary: TBD Based on Experience (Paid Weekly - Benefits Available)Employment Type: 6 month Contract
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products. Knowledge/Skills Requirements: Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility. Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples. Ability to isolate and sub-culture microorganisms for identification. Provides input on SOP revisions and may assist in the creation and editing of protocols Builds credibility within the lab group by performing high quality work Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity Compilation and trending of Environmental Monitoring data for reporting purposes Report and investigate environmental monitoring excursions. Effectively communicates results of own work through discussions and documentation with some input from supervisor Flexibility in following unique campaign requirements that may include off-hour and weekend work Other duties as assignedSKILLS & TECHNICAL EXPERTISE: Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision Experience with viable and non-viable Environment Monitoring collection instruments. Creative individual with outstanding trouble shooting skills Concentration of aseptic technique and contamination control Streak plating and microbial identification Document writing, data interpretation, presentation, statistical analysis and trending a plus Minimum supervision required on day-to-day activities and accomplished tasks Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisorQualifications: B.S. or A.S. in a Life Sciences discipline and 1-4 years of relevant experience working in cGMP cleanrooms Experience working in cGMP Quality Control Experience with Microsoft Office Strong attention to detail Familiarity with Good Manufacturing Practices (cGMP s) Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasksMEASUREMENT OF PERFORMANCE: Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team Dependable and can work with minimal supervision on scheduled tasks Timeliness and accuracy in completion of projects and documentation (quantity of work) Contributions to projects beyond general responsibilities (quality of work) Identification of problem areas affecting operations (knowledge/problem solving) Offers suggestions for correcting problems and for improving operations Exercises good judgment in dealing with operational problems Understanding of theory, rationale behind tasks performed Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs Ability to succeed in a team-oriented environment under very dynamic conditionsEOE/ADA