Overview
Quality Assurance Manager Jobs in Boerne, TX at Allcat Claims Service
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
Job Types: Full-time, Temp-to-hire
Pay: $26.63 – $27.51 per hour
Schedule:
8 hour shift
Monday to Friday
Experience:
Pharmaceutical Quality Control: 3 years (Preferred)
Monitoring surfaces, air, quality of ISO 5, 7,: 3 years (Preferred)
Shift availability:
Night Shift (Preferred)
Day Shift (Preferred)
Ability to Relocate:
Winchester, KY: Relocate before starting work (Required)
Work Location: On the road
Title: Quality Assurance Manager
Company: Allcat Claims Service
Location: Boerne, TX
