QC Analyst - Microbiology (Contractor)- 2nd Shift jobs in United States
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Genezen · 1 day ago

QC Analyst - Microbiology (Contractor)- 2nd Shift

Genezen is a company focused on gene therapy, providing process development and GMP viral vectors for clinical trials. The QC Analyst will be responsible for routine and non-routine QC sampling and testing, ensuring product quality and safety in a cGMP environment.

BiotechnologyGeneticsManufacturing
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Responsibilities

Perform routine/non-routine environmental monitoring of cGMP environments
Perform routine/non-routine sampling of utility systems
Perform routine/non-routine testing and review of cGMP samples in accordance with Standard Operating Procedures (Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Microbial Identification, Biological Indicator)
Performs peer review with minimal errors
Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc
Assist with data trending and aid in compilation of trend reports
Support shipment of samples to contract testing laboratories, as required
Support of quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls
Maintain QC Microbiology related systems in compliance with industry standards

Qualification

MicrobiologyCGMP complianceQC testingLIMS proficiencyEnvironmental MonitoringCommunication skillsOrganizational skillsTime managementDetail orientedFlexibility

Required

BA or BS in Microbiology or other related science
Minimum 0-3 years of laboratory base experience within QC testing capacity, preferably in cGMP environment
Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+
Understanding of industry testing requirements/standards
Proficiency in computer applications including MS Word, Excel, and LIMS (preferred)
Good/effective communication, organizational, and time management skills with the ability to work well with others and independently
Flexibility and willingness to learn, with a proactive approach to making a positive impact
Detail Oriented
Adaptability required as work schedule may change based on business needs
Criminal background check required

Preferred

Proficiency in computer applications including MS Word, Excel, and LIMS (preferred)

Benefits

Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary, vested immediately
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance

Company

Genezen

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Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services.

Funding

Current Stage
Growth Stage
Total Funding
$18.5M
Key Investors
Ampersand Capital Partners
2023-11-02Series Unknown· $18.5M

Leadership Team

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Steven J. Favaloro
Chairman & CEO
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Michael Wourms
Chief Operations Officer
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Company data provided by crunchbase