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16 days old

QC Micro Scientist

Kelly Services
Parsippany, NJ 07054
Kelly Science has a great opportunity as a **QC Micro Scientist in Parsippany NJ** !


You will lead in experimental design, method validation/qualification, equipment qualification and technical transfer activities of compendial methods related to raw materials and finished product.


**Responsibilities:**

Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory.

Executes microbiological methods using, but not limited to, Bioburden testing, Microbial Limits Testing, Antimicrobial Effectiveness Testing, Sterility Testing, and Bacterial Endotoxin Testing, and Microbial and Fungal Identification.

Executes stability program including pulling, testing, submitting to external laboratories and protocol and report generation.

Performs training of new hires and assists junior analysts with water sampling, environmental sampling routine/batch, gas testing, gown qualification and media fills.

Oversee environmental performance qualification of new cleanroom areas. Performs risk assessments and develops sampling plans and site maps for new cleanroom areas.

Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending.

Supports research laboratories on experimental design and method qualification of clinical or pre-clinical products.

Perform configuration of new analyses, products and specifications in LIMS as necessary.

Communicates with vendors for laboratory needs.

Creates, reviews, and performs authorization of GMP data on paper, logbooks and in LIMS, including but not limited to test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc. Ensures adherence to regulatory agency requirements, ICH guidelines, Ferring standards and procedures.

Monitors the life cycle microbiology instruments for preventative maintenance and calibration - ensuring conformance to specifications. Ensures lab equipment conforms to specifications. Oversees the execution of IQ/OQ/PQ of new purchased instruments in a timely manner. Troubleshoots instruments in the lab when necessary.

Issues deviations, laboratory investigations, corrective actions change controls, and monitors effectiveness checks in LIMS and in QA-Track


**Requirements:**

Bachelor of Science Degree in Biological or Environmental Sciences from an accredited College or University is required. Master of Science degree preferred.

A minimum of 8 years of QC laboratory (pharmaceutical or biopharmaceutical industry) with a Bachelors Degree or 4 years of industry experience with a Masters degree.

Strong preference for experience in the following:

Cell/Gene Therapy

TT Activities

Cell-Based Assay (ELISA, PCR)

Rapid Microbial Methods

Knowledgeable in Labware LIMS configuration of new analyses and product specification.

Microbiological method development, transfer, and validation experience is highly preferred.

Knowledge of USP/EP/cGMP and ICH guidelines; Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise); Microsoft Office; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.


Interested? Please apply now!


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-01 Expires: 2021-11-01

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QC Micro Scientist

Kelly Services
Parsippany, NJ 07054

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