Job Title: QC Analyst
Location: Winchester, KY 40391.
Duration: 6 months Contract to Hire
Pay Rate: $27.76/hr. on W2 (WITHOUT BENEFITS)
LOCAL CANDIDATES PREFERRED
TEMP TO HIRE - SHIFT - SAT, SUN, MON 6AM - 6PM AND BIWEEKLY TUES 6AM - 2:30PM
Description/Comment:
"Paragon Gene Therapy is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices 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 Paragon 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.
Key Responsibilities include but are not limited to:
• 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.
Experience & Education:
• 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
...Position: Physical Security Operations Center Regional Manager Datacenter Physical Security Reports To: Physical Security Operations Center Global Manager Location: San Antonio, TX FLSA: Exempt SUMMARY: The Physical Security Operations Center Regional...
...excellent benefit package. Relocation assistance provided. *Application deadline: 2/28/2025. The Finance Director / Deputy City Manager works closely with the City Manager, City Clerk and Department Heads in accomplishing the goals and directives of the City Council...
...Job Hours: 8:30am-7:00pm EST- timeframe. Monday-Friday Job Schedule:5 days in office TEMP TO PERM: Yes JOB SUMMARY Often the first point of contact for customers, the Loyalty Services Specialist is responsible for addressing customer service concerns, inquiries...
...CALL (***) ***-**** or apply now APPLY NOW! Have Your Amazing 2025! The sky's the limit! CDL A Owner Operator or fleet owner Position with great pay and home time for work/life balance. We value you and your family. Trucking is a family decision. We are currently...
...opportunities throughout our network of facilities in S.C. Referral bonuses Appreciation events throughout the year Nursing school loan repayment PTO for your birthday Successful candidates will have the following: Must maintain all required...