What are the responsibilities and job description for the QC Analyst position at MEDVACON TALENT ACQUISITION, LLC?
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in@medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately tojobs@medvacon.com.
This is a contract-to-hire position.
TEMP TO HIRE - SHIFT - MON-FRI 3PM - 11:30PM
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:
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Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in@medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately tojobs@medvacon.com.
This is a contract-to-hire position.
TEMP TO HIRE - SHIFT - MON-FRI 3PM - 11:30PM
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
- 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
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