QC Analyst
BC Forward

QC Analyst

BCforward is looking for highly motivated QC Analyst in Winchester, KY

Title: QC Analyst
Location: Winchester, KY
Duration: Contract

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 (cGMPs)
* 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

Interested candidates please send resume in Word format Please reference job code 220272 when responding to this ad.

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Job Snapshot

Employee Type
Contractor

Location
Winchester, KY (Onsite)

Job Type
Pharmaceutical

Experience
Not Specified

Date Posted
03/20/2024