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Microbiologist 2nd Shift

Employer
Quva Pharma
Location
Sugar Land, Texas, US
Salary
Competitive
Closing date
Oct 22, 2021

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
Job Description
2nd Shift:

Position Overview:

Performs individual hands-on work in the sterility testing program. The Microbiologist provides scientific guidance and interpretation of environmental monitoring and microbiology results to production management.

Responsibilities may include:
  • Compiles and interprets results of environmental monitoring tests and sterility results;
  • Conducts investigations of all non-conforming results;
  • Identifies environmental microbial isolates by classical techniques and automated identification methods to meet the requirements of the microbial environmental monitoring program;
  • Evaluates cleaning effectiveness on a routine basis to determine robustness of disinfection.
  • Develops and/or performs water sampling, including DI water, WFI and steam per the program (when needed);
  • Performs and/or oversees surface and air sampling of the facility areas and equipment per the program;
  • Performs and/or oversees environmental monitoring of all facility areas in compliance with gowning requirements;
  • Validates methods and perform sterility (USP ), Scan RDI and endotoxin (USP ) testing for finished goods;
  • Performs growth promotion testing of media;
  • Prepares reports and communicate results for the environmental program per facility standards;
  • Trains and maintains current training status on required equipment and procedures;
  • Perform other duties as assigned.

Qualifications:
  • Legally authorized to work in the job posting country
  • Must have a B.S. degree in related field (preferably Microbiology)
  • 0-2 years of experience in Microbiology, preferably in pharmaceutical manufacturing
  • Previous training and experience in environmental monitoring, sampling and laboratory microbiology (USP 71, Growth Promotion Testing, Methods Validation)
  • In-depth knowledge of environmental monitoring, sampling and the microbial testing and microbial method validation requirements. Experience with Rapid Microbiological testing methods a plus.
  • Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing.

To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
Company DescriptionQuVa Pharma is a leader in 503B outsourced compounding, serving all 50 states with a full portfolio of sterile, ready-to-administer injectable products. QuVa was purpose-built to change the 503B industry for the better and is leading the way in making it more safe, efficient, and reliable. With unmatched expertise in cGMPs and sterile pharmaceutical manufacturing, we achieve higher than required quality and safety standards and maintain a leading FDA compliance record, so hospitals can more confidently and reliably focus on patient care. While our leading cGMP processes, sterile-to-sterile portfolio, and expansive capacity of 300,000 sq ft across four facilities are the foundation of success, it is our transparency, customer-focused service, and contracted supply arrangements that enable us to help hospitals and health systems better meet their patient care and operational needs.

As FDA compliance becomes more stringent, QuVa's ability to reliably supply the highest-quality products is more valuable than ever and allows hospitals to spend more time on patient care and less time worried about beyond use dates, waste, workload inefficiencies, and compliance. That is why QuVa is proud to be recognized as the partner of choice for many of the nation's leading health systems. So, whether you are calling for a response or being called on for a solution, know that QuVa is accountable, and in us, you always have an answer.

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