What are the responsibilities and job description for the QC Analyst position at The Staffing Resource Group, Inc?
QC Analyst
SRG 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 Analyst
Location : Winchester , KY
Industry : Pharmaceutical
Hours : MON-FRI 11PM - 7 : 30AM
Salary : up to $27.76 (Paid Weekly - Benefits Available)
Employment Type : Contract to hire
Position Summary : Client provides process development and GMP manufacturing services for Phase I / II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a contract employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I / II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill / finish.
Responsibilities :
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 work
Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
Performs media fills and fill / finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
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
May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.
Qualifications
Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
Experience working in cGMP Quality Control
Experience with Microsoft Excel and Microsoft Word
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 tasks
Must be able to work off hours or weekends as required
LIMS or MODA experience a plus
Experience conducting bioburden and membrane filtration testing a plus
Keep a pulse on the job market with advanced job matching technology.
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